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BION3
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ACTOFEN EXTRA
ERIOPHOS
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LETIZEN
ULTOP
NOLPAZA
METOVER
ACTOFERON
ACTOFERON
Interferon beta 1b 300 mcg
Lyophilized vials, prefilled syringes of
solvent
Please read this leaflet carefully before you
start to use Actoferon and each time your prescription is refilled since there
may be new information. The information in this medication guide does not take
the place of talking with your doctor.
What is Actoferon?
Actoferon is a type of protein called beta
interferon that occurs naturally in the body. It is used to treat relapsing
forms of multiple sclerosis. It will not cure your MS but may decrease the
number of flare-ups of the disease. MS is a lifelong disease that affects your
nervous system by destroying the protective covering (myelin) that surrounds
your nerve fibers. The way Actoferon works in MS is not known.
Who should not take Actoferon?
Do not take Actoferon if you have had an
allergic reaction such as difficulty breathing, flushing or hives to another
interferon Beta or human albumin.
If you have depression, anxiety, trouble
sleeping, liver diseases, problems with your thyroid gland, blood problems,
epilepsy or you are planning to become pregnant, you should tell your doctor
before taking Actoferon.
If you become pregnant while taking Actoferon
you should stop using Actoferon immediately and call your doctor. Actoferon may
cause you to lose your baby (miscarry) or may cause harm to your unborn child.
You and your doctor will need to decide whether the potential benefit of taking
Actoferon is greater than the potential risks to your unborn child.
You should tell your doctor if you are taking
any other prescription or nonprescription medicines. This includes any vitamin
or mineral supplements, or herbal products.
How should I take Actoferon?
Actoferon is given by injection under the
skin every other day. Your injections should be approximately 48 hours (two
days) apart, so it is best to take them at the same time each day. If you miss
a dose, you should take your next dose as soon as you remember or are able to
take it.
What should I avoid while taking Actoferon?
You should avoid becoming pregnant until you
have talked with your doctor. You should also talk to your doctor if you are
breast feeding an infant.
What are the possible side effects of
Actoferon?
Flu-like symptoms: Most patients have fever,
chills, sweating, muscle aches and tiredness.
You should talk to your doctor about taking
medication for pain or fever reduction.
Skin reactions: Soreness, redness, pain,
bruising or swelling may occur at the place of injection.
Depression and anxiety: There have been
patients taking interferons who had thoughts about killing themselves. If you
feel sad or hopeless you should call your doctor.
Liver problems: If you develop symptoms of
changes in your liver, including yellowing of the skin and whites of the eyes
and easy bruising, call your doctor immediately.
Blood problems: You may have a drop in the
levels of infection-fighting blood cells, red blood cells or cells that help to
form blood clots. If the drop in levels are severe, they can lessen your
ability to fight infections, make you feel tired or sluggish or cause you to
bruise or bleed easily.
Thyroid problems: Your thyroid function may
change. Symptoms of changes in the function of your thyroid include feeling
cold or hot all the time, change in your weight without a change in your diet
or amount of exercise you are getting.
Allergic reactions: Some patients have hives,
rash, skin bumps, itching or swelling of the mouth and tongue. Other patients
have more serious allergic reactions such as difficulty breathing and
swallowing. Allergic reactions can happen after your first dose or may not
happen until after you have taken Actoferon many times. If you think you are having
an allergic reaction, stop using Actoferon immediately and call your doctor.
Whether you experience any of these side
effects or not, you and your doctor should periodically talk about your general
health. Your doctor may want to monitor you more closely and ask you to have
blood tests done more frequently.
Call your doctor for medical advice about
side effects.
Instructions for Preparing and Giving
Yourself an Injection of Actoferon
1. Find a clean, flat working surface that is
well-lit and collect all the supplies you will need to give yourself an
injection. You will need:
One tray containing Actoferon. Make sure the
tray contains:
• A pre-filled diluent syringe
• A vial of Actoferon
• Two needles (a green needle to reconstitute
the powder and a gray needle to apply the injection).
2. Open the tray and take out all the
contents. Check to make sure the rubber cap on the diluent syringe is firmly
attached.
3. Wash your hands thoroughly with soap and
water.
4. Check the expiration date on the vial and
syringe to make sure that it has not expired. Do not use it if the medication
has expired.
Reconstituting Actoferon
1. Take the cap off the Actoferon vial.
2. Use an alcohol pad to clean the top of the
vial. Move the pad in one direction. Leave the alcohol pad on top of the vial
until step 5.
3. Peel the label off the blister pack with
the green needle in it, and remove the needle by its green plastic edge.
4. Remove the cap from the syringe and place
the green needle in the tip of the needle.
5. Remove the alcohol pad from the top of the
Actoferon vial. Place the syringe on top of the Actoferon vial and push down on
the syringe until it pierces the rubber top of the Actoferon vial.
6. Slowly push the plunger of the diluent
syringe all the way in. This will transfer all of the diluent in the syringe to
the Actoferon vial. Continue to hold the plunger in during the mixing process;
otherwise the plunger may return to its original position after you release it.
7. Gently swirl the vial to completely
dissolve the white cake of Actoferon. Do not shake. Shaking can
cause Actoferon to
foam; even gently
mixing the solution
can cause foaming. If there is
foam, allow the vial to sit undisturbed until the foam settles.
8. After the cake is dissolved, look closely
at the solution to make sure the solution is clear and colorless and does not
contain particles. If the mixture contains particles, or is discolored, do not
use. Verify that the vial is not cracked or damaged. Do not use cracked or
damaged vials.
Preparing the Injection
You have
completed the steps
to reconstitute your Actoferon and
are ready for
the injection. The injection should be given immediately after mixing
and allowing any foam in the solution to settle. If you must delay giving yourself
the injection, you may refrigerate the solution and use within three hours of
reconstitution. Do not freeze.
1. With your thumb still pushing the plunger,
turn the syringe assembly so that the vial is on top.
2. Slowly pull the plunger back to withdraw
the entire contents of the Actoferon vial into the syringe.
3. Turn
the syringe assembly
so that the
needle end is pointing
up. Remove any air bubbles by tapping the outer wall of the syringe with
your fingers. Slowly push the plunger to the 1 mL mark on the syringe or to the
amount prescribed by your doctor.
NOTE:
If too much solution is pushed into the vial, repeat steps 1, 2, and 3.
4. Turn the syringe assembly so that the vial
is at the bottom. Remove the vial from the syringe.
5. Remove the green needle from the syringe
and replace it by the gray needle.
Picking an Injection Site
Actoferon (Interferon beta 1b) is injected
under the skin and into the fat layer between the skin and the muscles (subcutaneous
tissue). The best areas for injection are where the skin is loose and soft and
away from the joints, nerves, and bones. Do not use the area near your navel or
waistline. If you are very thin, use only the thigh or outer surface of the arm
for injection.
You should pick a different site each time
you give yourself an injection.
You should not choose the same area for two
injections in a row.
Keeping a record of your injections will help
make sure you rotate your injection sites.
You should decide where your injection will
be given before you prepare your syringe for injection. If there are any sites
that are difficult for you to reach, you can ask someone who has been trained
to give injections to help you.
Do not inject in a site where the skin is red,
bruised, infected, or scabbed, has broken open, or has lumps, bumps, or pain.
Tell your doctor or healthcare provider if you find skin conditions like the
ones mentioned here or any other unusual looking areas where you have been
given injections.
Using a circular motion, and starting at the
injection site and moving outward, clean the injection site with an alcohol
swab. Let the skin area dry before you inject the Actoferon. Remove the cap
from the gray needle.
Hold the syringe like a pencil or dart in one
hand.
Gently pinch the skin around the site with
the thumb and forefinger of the other hand. While holding your skin, stick the
needle straight into the skin at a 90° angle with a quick, firm motion.
Slowly push the plunger all the way in until
the syringe is empty. Remove the needle
from the skin;
then place a gauze
pad over the injection site. Gently massage the
injection site for a few moments with the gauze pad.
Throw away the syringe in a disposal
container.
Disposing of syringes and needles
Used
needles and syringes may be placed in a container made specially for
disposing of used syringes and needles,
or a hard plastic
container with a screw-on
cap or metal container with a plastic
lid labeled "Used
Syringes". Do not use glass
or clear
plastic containers. You should always check with your healthcare
provider for instructions on how to properly dispose of used vials, needles and
syringes.
DO NOT throw the needle or syringe in the
household trash or recycle. Always keep the disposal container out of the reach
of children.
How should Actoferon be stored?
Actoferon should be stored in 2°– 8°C refrigerator in the original package.
Do not freeze.
How supplied
Actoferon is supplied as a lyophilized powder
containing 300 mcg of Interferon beta 1b,
15 mg human albumin and 15 mg mannitol in a
clear glass vial, a prefilled single use syringe containing 1.2 ml of diluent
(sodium chloride, 0.54% solution), two needles (to reconstitute and to inject)
and an alcohol swab. Actoferon and the diluent are for single use only. Unused
portions should be discarded.
Rx Only
ACTOVEX
CIPRINOL
FROMILID
SUPRIMUN
EQUIN VAGINAL CREAM
EQUIN
CYCLOGEST
Cyclogest® 400mg pessary
Progesterone
Cyclogest is the registered trademark of L.D.COLLINS and CO., Limited
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, health care provider or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist.
What is in this leaflet
1. What Cyclogest is and what it is used for
2. Before you use Cyclogest
3. How to use Cyclogest
4. Possible side effects
5. How to store Cyclogest
6. Further information
1. What Cyclogest is and what it is used for
Cyclogest contains progesterone which is a natural, female sex hormone, produced in the body.
Cyclogest works by adjusting the hormonal balance within the body for the treatment of:
- pre-menstrual syndrome which often affects women during the 7 to 10 days before their monthly period. The symptoms of pre-menstrual syndrome include feelings of tension, irritability, depression, headache, breast tenderness, weight gain and bloatedness
- post-natal depression which some women get after their baby has been born.
- also be used for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme.
2. Before you use Cyclogest
a. Do not use Cyclogest:
- if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6),
- if you have known or suspected tumour that is hormone sensitive,
- if you have porphyria disorders (a group of inherited or acquired disorders of certain enzymes),
- if you have or have had blood clots in the legs, lungs, eyes or elsewhere in the body,
- if you currently have or have had severe liver problems.
- if you have a miscarriage and your physician suspects some tissue is still in the uterus or pregnancy outside of the womb.
b. Take special care with Cyclogest
Talk to your doctor, health care provider or pharmacist before using Cyclogest.
Take special care and tell your doctor straight away if you experience any of these symptoms during treatment or even few days after the last dosage:
- pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs
- severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg indicating possible clots in the brain or eye
- worsening of depression
Check with your doctor or pharmacist before using Cyclogest if you have or ever have had:
- liver problems such as jaundice (yellowing of the skin and whites of the eyes).
- epilepsy
- migraine
- asthma
- cardiac or renal dysfunction
- diabetes
c. Other medicines and Cyclogest
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important in case you are taking carbamazepine (e.g. to prevent fits, treat certain type of pain or mood disorders), rifampicin (to treat infections) or phenytoin (e.g. to prevent fits or treat certain type of pain) as they may decrease the effectiveness of progesterone.
Using other vaginal products at the same time as Cyclogest is used vaginally is not recommended as it is not known if it affects the treatment.
d. Children
There is no relevant use of Cyclogest in children.
e. Pregnancy and breast-feeding
Cyclogest can be used during the first trimester of pregnancy for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme.
The risks of congenital (conditions present at birth) anomalies, including genital abnormalities in male or female infants, from exposure to exogenous progesterone during pregnancy have not been fully established.
For other use, if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
This medicine should not be used during breast feeding.
3. How to use Cyclogest
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
For women undergoing Assisted Reproductive Technology (ART) programme:
The recommended dose is 400 mg twice a day by vaginal insertion. Start using Cyclogest 400 mg on the day of egg retrieval. The administration of Cyclogest should be continued for 38 days if pregnancy has been confirmed.
For the treatment of premenstrual syndrome and post-natal depression:
The recommended dose is 200 mg once a day or 400 mg twice a day by vaginal or rectal insertion.
The pessary may be inserted into either the vagina or rectum (back passage) depending upon the following certain other conditions.
You should insert Cyclogest into the:
• vagina if you have:
- colitis (inflammation of the colon causing frequent attacks of diarrhoea with mucous or blood)
- problems controlling your bowel movements (faecal incontinence).
• rectum (back passage) if you have:
- a vaginal infection (discharge from your vagina)
- or often have cystitis (a burning pain on passing water)
- recently given birth
- to use a barrier method of birth control such as a diaphragm, cap or condom. Such devices may not work properly in the presence of the vegetable fat from the pessary.
For premenstrual tension start using Cyclogest on day 12 or 14 of your menstrual cycle. This can be planned and marked onto your calendar; day 1 is the first day of your monthly period, counting forward to day 12 or 14 as advised by your doctor.
Do not swallow Cyclogest.
Method and route of administration
Always wash your hands before and after inserting the pessary.
To insert into the:
• Vagina - place the pessary between the lips of the vagina and push the pessary upwards and backwards. You may find it easier to do this if you are lying down or squatting.
• Rectum (back passage) - gently push the pessary into the rectum for about one inch. Your muscles will hold the pessary in place when it is in far enough. Squeeze your buttocks together for a few seconds.
a. If you use more Cyclogest than you should
If you (or someone else) has accidentally swallowed any of the pessaries or you use too many, contact your nearest hospital casualty department or your doctor immediately for advice.
b. If you forget to use Cyclogest
If you forget to insert a pessary, do so as soon as you remember, unless it is nearly time for the next dose. Never use two doses together. Remember to use the remaining doses at the correct time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions in patients undergoing ART treatment is presented below:
The following common side effects (may affect up to 1 in 10 people):
- Abdominal distension (swelling in the abdomen), abdominal pain, constipation
- Sleepiness
- Tiredness
- Hot flush
- Breast pain
The following uncommon side effects (may affect up to 1 in 100 people):
- Headache, dizziness, mood changes
- Change in taste, vomiting, flatulence (wind), diarrhoea, bloat (gastric dilatation), rectal tumour
- Night sweats, skin rash or itching
- Joint pain
- Pelvic pain, ovarian enlargement, vaginal bleeding
- Frequent urination, involuntary excretion of urine
- Weight increase
- Bleeding
- Itching at the application site, feeling cold or body temperature change or general discomfort
Following rectal administration, soreness in rectum (back passage), diarrhoea and flatulence may occur.
When treated for premenstrual syndrome or post-natal depression you do not need to worry if you find changes in your menstrual cycle. You may find that your monthly period will start earlier than usual or it may be delayed.
After using Cyclogest you may notice some leakage after the pessary has dissolved. Do not worry, this is quite normal when using medicines that are inserted into the vagina or rectum.
5. How to store Cyclogest
Keep this medicine out of the sight and reach of children.
Store below 25C in a dry place.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
a. What Cyclogest contains
- The active substance (the ingredient that makes the medicine work) is progesterone. Each pessary contains 400 mg of the active ingredient.
- The other ingredients are vegetable fat.
b. What Cyclogest looks like and contents of the pack
Cyclogest are off-white pessaries.
Pack sizes are 15.
c. Marketing Authorisation Holder and Manufacturer
Actavis UK Limited ,
Barnstaple, EX32 8NS, United Kingdom.
d. This leaflet was last revised in 02/ 2016, version number 01
e. For any inquiries related to Cyclogest, please forward to:
MIRPMiddleEast@actavis.com
For any inquiries related to Pharmacovigilance , please forward to:
PLRPMiddleEast@actavis.com
Further Information:
Premenstrual Syndrome
Many women suffer from a condition called premenstrual syndrome or PMS. This is commonly known as PMT (premenstrual tension) because of the anxiety and bad temper often associated with it. However, there are many other symptoms that occur with PMS including depression, bloating and breast tenderness. It is not just your symptoms that decide whether you have PMS but the time at which they are at their worst.
PMS is characterised by the symptoms that occur during the days leading up to your period and are then completely relieved by menstruation. The cause of PMS is not completely understood but it is believed to be related to the hormonal changes that occur during the monthly cycle. Many women obtain relief from their symptoms when their hormonal balance is altered with a medicine prescribed by their doctor.
Post-Natal Depression
Many mothers experience short-term periods of mild depression following the birth of their baby. This is a common condition, usually occurring three or four days after delivery, affecting at least half of all new mothers who may feel tearful, overwhelmed and irritable during this time. Support, reassurance and rest can help these feelings to pass within a few days.
However, if the anxiety does not improve, the mother may be developing postnatal depression. Up to 15 per cent of new mothers develop more severe symptoms within 12 months of their child’s birth. Postnatal depression (PND) is characterised by marked low mood for a more prolonged period of time.
Though it may take several weeks or months until a full recovery is reached, PND is a treatable condition from which the mother will get better.
Speak to your doctor, healthcare provider or pharmacist if you have any further questions.
This is a Medicament
- Medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you.
- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children
Council of Arab Health Ministers
Union of Arab Pharmacists
Logo Actavis
Actavis UK Limited, Barnstaple, EX32 8NS, United Kingdom
HYDRAPRES
NOXPRIN
ACTOLOL
GEMFACTO
ATOREXIN
LOSAVER
LIPITOR
ZYLLT
Zyllt 75 mg film-coated tablets
Clopidogrel
Read all of this leaflet carefully before you start taking
this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your
pharmacist.
- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
- If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet
1. What Zyllt is and what it is used for 4.
Possible side effects
2. What you need to know before you take Zyllt 5. How to store Zyllt
3. How to take Zyllt
6. other information
1. What Zyllt is and what it is used for
Zyllt contains clopidogrel and belongs to a group of medicines
called antiplatelet medicinal products. Platelets are very small structures in
the blood, which clump together during blood clotting. By preventing this
clumping, antiplatelet medicinal products reduce the chances of blood clots
forming (a process called thrombosis).
Zyllt is taken by adults to prevent blood clots (thrombi)
forming in hardened blood vessels (arteries), a process known as
atherothrombosis, which can lead to atherothrombotic events (such as stroke,
heart attack, or death).
You have been prescribed Zyllt to help prevent blood clots
and reduce the risk of these severe events because:
- You have a condition of hardening of arteries (also known
as atherosclerosis), and
- You have previously experienced a heart attack, stroke or
have a condition known as peripheral arterial disease, or
- You have experienced a severe type of chest pain known as
‘unstable angina’ or ‘myocardial infarction’ (heart attack). For the treatment
of this condition your doctor may have placed a stent in the blocked or
narrowed artery to restore effective blood flow. You should also be given
acetylsalicylic acid (a substance present in many medicines used to relieve
pain and lower fever as well as to prevent blood clotting) by your doctor.
- You have an irregular heartbeat, a condition called
‘atrial fibrillation’, and you cannot take medicines known as ‘oral
anticoagulants’ (vitamin K antagonists) which prevent new clots from forming
and prevent existing clots from growing. You should have been told that ‘oral
anticoagulants’ are more effective than acetylsalicylic acid or the combined
use of Zyllt and acetylsalicylic acid for this condition. Your doctor should
have prescribed Zyllt plus acetylsalicylic acid if you cannot take ‘oral
anticoagulants’ and you do not have a risk of major bleeding.
2. What you need to know before you take Zyllt
Do not take Zyllt:
• If you are allergic to clopidogrel or any of the other
ingredients of this medicine (listed in section 6).
• If you have a medical condition that is currently causing
bleeding such as a stomach ulcer or bleeding within the brain.
• If you suffer from severe liver disease.
If you think any of these apply to you, or if you are in any
doubt at all, consult your doctor before taking Zyllt.
Warnings and precautions
If any of the situations mentioned below apply to you, you
should tell your doctor before taking Zyllt:
• if you have a risk of bleeding such as
- a medical condition that puts you at risk of internal
bleeding (such as a stomach ulcer)
- a blood disorder that makes you prone to internal bleeding
(bleeding inside any tissues, organs or joints of your body).
- a recent serious injury
- a recent surgery (including dental)
- a planned surgery (including dental) in the next seven
days
• if you have had a clot in an artery of your brain
(ischaemic stroke) which occurred within the last seven days
• if you have kidney or liver disease
• if you have had an allergy or reaction to any medicine
used to treat your disease.
While you are taking Zyllt:
• You should tell your doctor if a surgery (including
dental) is planned.
• You should also tell your doctor immediately if you
develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura
or TTP) that includes fever and bruising under the skin that may appear as red
pinpoint dots, with or without unexplained extreme tiredness, confusion,
yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE
EFFECTS’).
• If you cut or injure yourself, it may take longer than
usual for bleeding to stop. This is linked to the way your medicine works as it
prevents the ability of blood clots to form. For minor cuts and injuries e.g.,
cutting yourself, shaving, this is usually of no concern. However, if you are
concerned by your bleeding, you should contact your doctor straightaway (see
section 4 ‘POSSIBLE SIDE EFFECTS’).
• Your doctor may order blood tests.
Children and adolescents
Do not give this medicine to children because it does not
work.
Other medicines and Zyllt
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including medicines obtained
without a prescription.
Some other medicines may influence the use of Zyllt or vice
versa.
You should specifically tell your doctor if you take
- oral anticoagulants, medicines used to reduce blood
clotting,
- a non-steroidal anti-inflammatory medicine, usually used
to treat painful and/or inflammatory conditions of muscle or joints,
- heparin or any other injectable medicine used to reduce
blood clotting,
If you have experienced severe chest pain (unstable angina
or heart attack), you may be prescribed Zyllt in combination with
acetylsalicylic acid, a substance present in many medicines used to relieve
pain and lower fever. An occasional use of acetylsalicylic acid (no more than
1,000 mg in any 24 hour period) should generally not cause a problem, but
prolonged use in other circumstances should be discussed with your doctor.
Pregnancy and breast-feeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant or suspect that you are pregnant, you
should tell your doctor or your pharmacist before taking Zyllt. If you become
pregnant while taking Zyllt, consult your doctor immediately as it is
recommended not to take clopidogrel while you are pregnant.
You should not breast-feed while taking this medicine.
If you are breast-feeding or planning to breast-feed, talk
to your doctor before taking this medicine. Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Zyllt is unlikely to affect your ability to drive or to use
machines.
Zyllt contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
Zyllt contains hydrogenated castor oil This may cause
stomach upset and diarrhoea.
3. How to take Zyllt
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you are not
sure.
If you have experienced severe chest pain (unstable angina
or heart attack), your doctor may give you 300 mg of Zyllt (4 tablets of 75 mg)
once at the start of treatment. Then, the recommended dose is one 75 mg tablet
of Zyllt per day to be taken orally with or without food, and at the same time
each day.
You should take Zyllt for as long as your doctor continues
to prescribe it.
If you take more Zyllt than you should
Contact your doctor or the nearest hospital emergency
department because of the increased risk of bleeding.
If you forget to take Zyllt
If you forget to take a dose of Zyllt, but remember within
12 hours of your usual time, take your tablet straightaway and then take your
next tablet at the usual time.
If you forget for more than 12 hours, simply take the next
single dose at the usual time. Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Zyllt
Do not stop the treatment unless your doctor tells you so.
Contact your doctor or pharmacist before stopping.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Contact your doctor immediately if you experience:
- fever, signs of infection or extreme tiredness. These may
be due to rare decrease of some blood cells.
- signs of liver problems such as yellowing of the skin
and/or the eyes (jaundice), whether or not associated with bleeding which
appears under the skin as red pinpoint dots and/or confusion (see section 2
‘Warnings and precautions’).
- swelling in the mouth or skin disorders such as rashes and
itching, blisters of the skin. These may be the signs of an allergic reaction.
The most common side effect is bleeding.
Bleeding may occur as bleeding in the stomach or bowels,
bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed,
blood in the urine. In a small number of cases, bleeding in the eye, inside the
head, the lung or the joints has also been reported.
If you experience prolonged bleeding when taking Zyllt
If you cut or injure yourself, it may take longer than usual
for bleeding to stop. This is linked to the way your medicine works as it
prevents the ability of blood clots to form. For minor cuts and injuries e.g.,
cutting yourself, shaving, this is usually of no concern. However, if you are
concerned by your bleeding, you should contact your doctor straightaway (see
section 2 ‘Warnings and precautions’).
Other side effects include:
Common side effects (may affect up to 1 in 10 people):
Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people):
Headache, stomach ulcer, vomiting, nausea, constipation,
excessive gas in stomach or intestines, rashes, itching, dizziness, sensation
of tingling and numbness.
Rare side effect (may affect up to 1 in 1000 people): Vertigo.
Very rare side effects (may affect up to 1 in 10,000
people):
jaundice; severe abdominal pain with or without back pain;
fever, breathing difficulties sometimes associated with cough; generalised
allergic reactions (for example, overall sensation of heat with sudden general
discomfort until fainting); swelling in the mouth; blisters of the skin; skin
allergy; sore mouth (stomatitis); decrease in blood pressure; confusion;
hallucinations; joint pain; muscular pain; changes in taste of food.
In addition, your doctor may identify changes in your blood
or urine test results. If you get any side effects, talk to your doctor or
pharmacist.
5. How to store Zyllt
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and blister after EXP. The expiry date refers to the last
day of that month.
Store in the original package in order to protect from
moisture and light.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away you no longer use. These measures
will help to protect the environment.
6. other information
What Zyllt contains
- The active substance is clopidogrel. Each film-coated
tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
- The other ingredients are anhydrous lactose (see section 2
‘Zyllt contains lactose’), microcrystalline cellulose, pregelatinised maize
starch, macrogol 6000, hydrogenated castor oil (see section 2 ‘Zyllt contains
hydrogenated castor oil’) in the tablet core and hypromellose (E464), titanium
dioxide (E171), red iron oxide (E172), talc and propylene glycol in the
filmcoating.
What Zyllt looks like and contents of the pack
The film-coated tablets are pink, round and slightly convex.
Boxes 28 film-coated tablets in blisters are available.
CORYOL
AMLOBER
VALSACOR
SUSTAC
RUBIFEN
LECTRUM
LectrumR Leuprolide acetate 3.75 mg, 7.5 mg lyophilized powder (microsphere) for injection – Reg. M.S. no: 1.0047.0410 Indications – Uterine fibroids; prostate cancer; endometriosis; puberty precocious Contraindications – Pregnancy and Lactation. Hypersensitivity to leuprolide acetate, similar nonapeptides or any of the formulation excipients sensitive to gonadorelin: synthetic gonadotropin – releasing hormone (GnRH); gonadotropin – releasing analogs (GnRH), such as buserelin, goserelin, histrelin, and nafarelin, also may be sensitive to leuprolide. Anaphylactic reaction to synthetic Gn-RH has been reported in medical literature. Precautions and Warnings prostate cancer – worsening of symptoms may contribute to paralysis with or without fatal complications (there are reports of isolated cases). Gynecological use – increasing of baseline values of sexual steroids. Increase in clinical signs and symptoms (beginning of therapy), that disappears with discontinuation of therapy. Do not administer to patients with undiagnosed abnormal vaginal bleeding. Puberty precocious – increase in clinical signs and symptoms (initial phase of therapy). Non-adherence to treatment or inadequate doses may result in inadequate control of the pubertal process (return of signs of puberty). Precautions Prostate cancer- Patients with vertebral metastases injuries and/or urinary obstruction should be observed during first weeks of treatment. Gynecological use- May occur bone loss that is reversible after discontinuation of six months treatment; Puberty precocious- Monitoring organic response 1 to 2 months after initiation of therapy, with a GnRH stimulation test and dosage of sexual steroids levels. Determination of bone age advancement should be performed every 6 – 12 months. Pediatric use (children and nursing mothers) – Only after puberty precocious treatment. Pregnancy and Lactation – It is not recommended during pregnancy and breast feeding. Caution when driving or operating machinery. Adverse reactions: prostate cancer: increase of testosterone levels. Special attention should be paid to patients with vertebral metastases and/or urinary obstruction or hematuria, may lead to neurological problem, as weakness and/or paresthesia of the lower extremities or worsening of urinary symptoms. Gynecological use – increase of estradiol levels may occur. Drug interaction: no pharmakinetic study of drug interactions was conducted with leuprolide acetate for injection. However drug interactions are not expected to occur, since leuprolide acetate is a peptide initially degraded by peptidase and not by cytochrome p450 enzymes as noted in specific studies, and the product is only 46% bound to plasma proteins. Posology and how to use – Lectrum should be administered under physician supervision. The recommended monthly dosage of Lectrum is: anemia due to uterine leiomyomas (fibroids) – intramuscular, 3.75 mg once a month, at most three months. Prostatic carcinoma – Intramuscular, 3.75 mg to 7.5 mg, once a month, by the time determined by physician. Endometriosis – intramuscular, 3.75 mg, for the maximum period of 6 months. Precocious puberty – Lectrum dose should be individualized for each child. The dose is based on the proportion of leuprolide mg per kg of body weight (mg/kg). The recommended initial dose is of 0.3 mg per body weight every 4 weeks (using a minimal total dose of 7.5 mg), administered in single dose intramuscular route, as follows: body weight less than or equal to 25 kg initial doses of 7.5 mg intramuscular every 4 weeks, body weight between 25 to 37.5 kg initial dose of 11.25 mg intramuscular every for weeks, body weight greater than 37.5 kg initial doses of 15.00 mg every 4 weeks. SALES UNDER MEDICAL PRESCRIPTION. THIS TEXT IS A SUMMARY, FOR DETAILED INFORMATION CONSULT THE LEAFLET OF THE PRODUCT.
EMOZUL
REBIF
CLOTOVER
LYRIVER
LOXEVER
LANSACTO
MESALOVER
ACTOSERC
ONDASTOVER
MEBACTO
MEBACTO
MOTILOVER
FASTOVER
ACTOPENTINE
ACTOLKAST