Clomed Tablets

Package leaflet: information for the user / patient

Clomed 50 mg film-coated tablets clomiphene

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 or pharmacist or nurse.
– This medicine has been prescribed for you only. You do not have to give it to others. It can harm them, even if they have the same signs of illness as yours.
– If you have any side effects, talk to your doctor or pharmacist or nurse. These include any possible side effects not mentioned in this leaflet. See section 4.

What you find in this leaflet:
1. What Clomed is and what it is used for
2. What you need to know before you are using Clomed
3. How to use Clomed
4. Possible side effects
5. How to store Clomed
6. Packaging content and other information.

1. What Clomed is and what it is used for
The effect of Clomed is to trigger the development of the ovum (so-called ovulation stimulation).
Therapeutic Indications for Women:
Stimulation of egg development in case of pituitary disorders or ovarian cancer and after long-term oral contraceptives. Elimination of pathological growth of milk secretion (galactoree) after birth.

2. What you need to know before you are using Clomed
Before using this medicine, talk to your doctor about the following risks:
– Ability to become pregnant with multiple children (multiple pregnancies).
– Pregnancy in which the baby develops outside the uterus (ectopic pregnancy).
– Increased risk of ovarian cancer.
– Ovarian hyperstimulation syndrome.
– Visual disturbances.
Any pregnancy may end with birth defects or abortion. This can happen even if you are not using Clomed.
Do not use Clomed:
– if you are allergic to clomiphene or any of the other ingredients of this medicine (listed in section 6).
– if you are pregnant. You have to perform a pregnancy test to make sure you are not pregnant before using Clomed.
– if you have liver disease or liver function disorder.
– if you have ovarian cysts or loss of pituitary function.
– if you have disorders of the thyroid or adrenal glands.
– if you have bleeding due to unknown causes or undiagnosed bleeding.
– if you have recent or pre-existing visual disturbances.
– if you have a type of cancer that can be aggravated by hormones.
– if you have an early menopause or have been told you are infertile.
Warnings and precautions
Before using Clomed, talk to your doctor or pharmacist:
– if you have no longer a menstrual cycle because you are underweight.
– if you have or have had seizures or seizures in the past.
– if you have uterine fibroids.
– if you have polycystic ovaries.
– if your ovaries are inflamed.
– if you have hypertriglyceridemia (excess fat in the blood) or a family history of hypertriglyceridemia.
Your doctor should check for any cause of infertility problems before starting treatment with Clomed.
Children and adolescents
This medicine should not be used in children and adolescents.
Clomed with other medicines
Please tell your doctor or pharmacist if you take or have recently taken any other medicines, including of those released without a prescription.
Pregnancy, breast-feeding and fertility
Clomed administration during pregnancy is contraindicated. Administration during breast-feeding can only be done after a careful risk/benefit assessment by the physician. Clomed can reduce lactation.
If you are pregnant or breast-feeding, you think you may be pregnant or if you intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
The medication may cause visual disturbances such as blurred vision, therefore, the limitation of vehicle driving or the use of equipment should be individually assessed by your doctor.
Important information about some Clomed components
Clomed tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency (Lapp), or glucose-galactose malabsorption should not take this medicine.
Clomed tablets contain FD @ C Yellow # 6 (E110) dye, which can cause allergic reactions.

3. How to use Clomed
Always use this medicine exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.
The recommended dose should be used once a day before a meal.
Treatment with women should always be preceded by a gynecological examination due to the occurrence of side effects. Clomed should be used strictly only for the indicated therapeutic indication and under permanent medical surveillance. In the case of infertility, the dosage and duration of treatment depend on sensitivity (a react to) the ovaries.
For regular menstruation, it is recommended to start treatment on the 5th day of the menstrual cycle (or on the 3rd day of the cycle in the case of early ovulation / follicular phase shorter than 12 days). If you do not have menstrual cycles, treatment can be started at any time.
Scheme no. 1:
50 mg/day over a 5-day period, meanwhile, ovulation development should be controlled by clinical examinations and laboratory investigations. Ovulation usually occurs between day 11 and 15 of the menstrual cycle. If there is no development of the ovum by applying this treatment, see Scheme no. 2.
Scheme no. 2:
Daily doses of 100 mg should be administered on a period of 5 days starting on day 5 of the following menstrual cycle. If neither ovulation develops after this treatment, can be repeated, the same scheme (100 mg/day). If the lack of ovulation persists, a 3-month treatment may be repeated after a 3-month discontinuation. Additional treatments are useless.
Treatment should be started at low doses (25 mg/day) in case of ovarian cysts (so-called ovarian polycystic ovary syndrome).
If there is no post-contraceptive menstrual cycle, a daily dose of 50 mg will be given; therapeutic effects usually occur on the fifth day of treatment, even when applying scheme no. 1.
This medicine should not be given to children, adolescents and postmenopausal women.
If you use more Clomed than you should
If you use more Clomed than you should, talk to a doctor or go to the hospital’s emergency department immediately. Take the medicine pack with you. You must do this so that the doctor knows what medicine you have used. You may cause hyperstimulation of your ovary (see section 4 below).
Symptoms seen after using more tablets than should be: nausea, vomiting, flushing, sweating, vision disturbances (blurred vision, bright dots, visual field gaps), enlarged ovaries with pelvic or abdominal pain.
In case of an overdose, it is recommended to remove the active substance and to administer a supportive treatment. Tell your doctor immediately in case of an overdose.
If you forget to use Clomed
If you forget a dose, talk to your doctor as you may need to change the cycle of treatment. Do not take a double dose to make up for the forgotten tablet. Continue the treatment in the same way and doses as prescribed. If you use this medicine irregularly as prescribed, then the expected effect may not be achieved.
If you stop using Clomed
In women, the drug is given for 5 days during menstruation. If you interrupt the administration before the expected, therapeutic effect will not be achieved.
If you have any further questions on this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not all people.
Stop using Clomed tablets and tell your doctor or go to hospital immediately if:
– You have an allergic reaction. Symptoms may include: rash, difficulty in swallowing or breathing, swelling of the lips, face, neck or tongue (angioedema).
– You have numbness, weakness or paralysis on one side of the body, blurred speech, sudden blurred vision, confusional state or changeover. These may be signs of a stroke.
– You are pregnant and have vaginal bleeding and abdominal pain. These may be signs of an extrauterine pregnancy (see section 2 above).
The frequency of the above mentioned adverse reactions is unknown (can’t be estimated from the available data).
Stop taking Clomed tablets and consult your doctor immediately, if you experience any of the following serious side effects – you may need urgent medical treatment:
Common (may affect up to 1 in 10 people):
– Blurred vision, spots or light spots on the field visual. These symptoms generally improve, but in some cases they may be permanent. Your doctor may ask for it eye examination.
Frequency not known (frequency can’t be estimated from the available data):
– Ovarian hyperstimulation. This may result in pelvic, abdominal or calf pain, swelling or bloating, urinary volume decrease, difficulty in breathing or growth in weight. If these symptoms occur, your doctor will lower your dose of Clomed.
– Liver problems that can cause yellowing of the eyes or skin (jaundice).
– Unexpected and severe headaches.
– Mental disorders such as “psychosis”.
Tell your doctor or pharmacist, if any of the following side effects gets serious or lasts for more than a few days:
Very common (may affect more than 1 in 10 people):
– Rinse of the skin.
– Abdominal pain or discomfort, weight gain, edema. This may be a sign of the growth of the ovaries.
Common (may affect up to 1 in 10 people):
– Feeling or feeling sick.
– Increase in menstrual pain intensity, abnormal bleeding or bleeding between menstruation.
– Breast pain.
– Headaches.
– Bloating and swelling.
Uncommon (may affect up to 1 in 100 people):
– Nerve stress more pronounced than normal.
– Problems of balance or dizziness (vertigo).
– Tiredness or trouble sleeping (insomnia).
– Condition of depression or mood swings or behavior.
Rare (may affect up to 1 in 1,000 people):
– Convulsions.
– Dark parts of the eye (cataract).
– Low vision, eye pain and difficulty in distinguishing some colors (optical neuritis).
Frequency not known (frequency can’t be estimated from the available data):
– Pain in the lower part of the stomach, weight gain, edema. This may be a sign of endometriosis (the situation where the mucosal cells inside the uterus are found in other parts of the body, for example in the muscles of the uterus) or its worsening and ovarian cancer.
– Increased ovarian growth.
– Multiple pregnancy, eg twins.
– Increased levels of fat in the blood (hypertriglyceridemia).
– Pain in the upper or lower abdomen. This may be a sign of inflammation of the pancreas (pancreatitis), which can be caused by an increased level of fat in the blood.
– Palpitations.
– Skin sores from the feet, arms, palms, hands, feet and inside the mouth (erythema polymorph).
– Visual disturbances.
– Feeling faint or loss of consciousness.
– Feeling of disorientation and speech problems.
– Rash on the skin or itching.
– Bruises.
– Swelling of the face, around the eyes, lip or tongue.
– Hair loss or thinning.
The sensation of heat waves observed during treatment disappears after it has been interrupted. Particularly in the case of rare diseases (so-called Stein-Leventhal syndrome), cystic enlargement of the ovaries may occur. Your doctor may require body temperature control and, depending on the results, may decide when to stop treatment. The possibility of occurrence of a gemular pregnancy and ectopic pregnancies is greater in women treated with clomiphene than in the normal population.
Reporting adverse reactions
If you experience any side effects, talk to your doctor or pharmacist. These include any possible side effects not mentioned in this leaflet. By reporting side effects, you can help provide additional information on the safety of this medicine.

5. How to store Clomed
Keep out of the reach and sight of children.
Keep protected from light and temperatures below 25 °C.
Do not use Clomed after the expiry date, which is stated on the pack after “EXP”. The expiration date refers to the last day of that month. No special storage conditions are required. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.

6. Packaging content and other information
What Clomed Contains
The active substance is clomiphene citrate.
1 film-coated tablet contains 50 mg of clomiphene citrate.
The other ingredients are: Core
Magnesium stearate, Kollidon CL (crospovidone), Ludipress (lactose monohydrate, polyvidone, crospovidone).
Coat
Copolymer of polyvinyl alcohol and polyethylene glycol, talc, dioxide titanium, mono and diglycerides of fatty acids, polyvinyl alcohol, colorant FD & C Yellow No.6 (E110), yellow iron oxide dye.
What Clomed looks like and contents of the pack
Round, biconvex, orange-coated tablets. In cross section, the internal contents of the tablet are white.
The contents of the packaging (20) film-coated tablets in PVC/Al blister.
Three (3) blister packs together with the patient leaflet are placed in a carton box.

CERTIFICATE OF REGISTRATION
SC Balkan Pharmaceuticals SRL N. Grădescu str., 4, MD-2002, or. Chisinau, Republic of Moldova.
The manufacturer
SC Balkan Pharmaceuticals SRL Industrial Street, 7 / A, MD-2091, or. Singera, Republic of Moldova.

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