CLOMID 50 mg Tablet

Зміст інструкції

1. CLOMID 50 mg tablets
   1. What is CLOMID and what is it used for
   2. What you need to know before you take CLOMID
   3. How to take CLOMID
   4. Possible side effects
   5. How to store CLOMID
   6. Contents of the pack and other information

CLOMID 50 mg tablets

Clomifene citrate

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What CLOMID is and what it is used for
• 2. What you need to know before you take CLOMID
• 3. How to take CLOMID
• 4. Possible side effects
• 5. How to store CLOMID
• 6. Contents of the pack and other information

1. What is CLOMID and what is it used for

CLOMID contains clomifene citrate as the active ingredient, which belongs to a group of medicines
known as synthetic ovulation stimulants.
CLOMID is used to promote the release of eggs from the ovaries (ovulation), in women who do not
have regular ovulation.
Treatment with CLOMID must be started and carried out under strict medical supervision.

2. What you need to know before you take CLOMID

Do not take CLOMID if:

• you are allergic to clomifene citrate or any of the other ingredients of this medicine (listed in section 6);
• you have or have had problems with your liver;
• you have vaginal bleeding (menometrorrhagia);
• you have tumors that may worsen due to hormones (hormone-dependent);
• you are pregnant (see “Pregnancy and breastfeeding”);
• you have an ovarian cyst not due to polycystic ovary syndrome, as it may enlarge. The doctor will assess the presence of ovarian cysts before each treatment cycle.

Warnings and precautions
Talk to your doctor or pharmacist before taking CLOMID.
Before starting treatment with CLOMID, your doctor will perform a thorough gynecological examination and
prescribe some tests to check your liver function.
Talk to your doctor before taking CLOMID if you have:

• fibroids in the uterus (benign tumors);
• cysts on the ovaries (fluid-filled sacs in the ovary);
• if you have had bleeding;
• you are in an advanced stage of your reproductive life;
• you are experiencing early menopause or have been told you are infertile or have thyroid, adrenal gland disorders or hyperprolactinemia (increased blood levels of prolactin) that may alter ovarian function;
• you have stopped having your period because you are underweight;
• a condition of the ovaries called “Polycystic Ovary Syndrome”, a condition that causes infertility, menstrual irregularities, excessive hair growth, severe acne;
• hypertriglyceridemia (an excess of fats in the blood) or a family history of hypertriglyceridemia.

Stop treatment with CLOMID and contact your doctor immediately if you experience during treatment
:

• visual problems, usually transient, such as blurred vision, flashing spots (photopsia), light sensitivity (photophobia), black spots in the field of vision (scotomas), double vision (diplopia) and inflammation of the eye veins (periphlebitis). In some cases, these symptoms may be permanent;
• lower abdominal pain, pain and feeling of fullness in the abdomen and/or weight gain, due to enlargement of the ovaries (ovarian hyperstimulation).

Other important information
Before taking CLOMID, discuss with your doctor the risk of:

• having a multiple pregnancy (twins);
• having an ectopic pregnancy (where the baby grows outside the uterus);
• possible fetal malformations or loss of the product of conception. Any pregnancy may lead to birth defects or miscarriage. This can happen even if the pregnancy was not induced with CLOMID;
• having problems with blood clotting;
• increased likelihood of having ovarian tumors.

For athletes: the use of this drug without a therapeutic need constitutes doping
and may still result in a positive doping test.

Other medicines and CLOMID
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

Pregnancy and breastfeeding
A pregnancy test should be performed before starting a new cycle of Clomid.
Do not use CLOMID if you are pregnant or think you may be.
If you are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and operating machinery
CLOMID can cause visual problems (see “Warnings and precautions”). If you experience such
symptoms, avoid driving vehicles or using machinery.

CLOMID containslactose and sucrose: if your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.

3. How to take CLOMID

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.

When treatment can be started

• If you have not had a menstrual period for the last few months, treatment can be started at any time.
• If you have regular menstrual periods (even if induced by drugs called progestogens), treatment should begin around the 5th day of the cycle.

Dose
The recommended dose is 1 tabletper day, for 5 days( first cycle).
If the first cycle of therapy is not effective, your doctor will prescribe a new cycle of treatment to
be performed after 30 days. The recommended dose in the second cycleis 2 tabletsper day (in
a single dose), for 5 days.
If the second cycle of therapy is also not effective, your doctor may prescribe a third cycle of
treatment, to be performed after 30 days. The usual dose in the third cycleis 2 tabletsper day
(in a single dose), for 5 days.
If no effects have been obtained after 3 cycles of therapy, your doctor may advise you to undergo specific
tests to verify any other problems with conception.

Method of administration
CLOMID is a medicine to be taken orally (oral use). Swallow the dose prescribed by your
doctor with water; do not chew or break the tablets. Do not exceed the indicated doses.

If you take more CLOMID than you should
you may notice the following symptoms: nausea and/or vomiting, hot flashes, blurred
vision, black spots in the visual field (scotomas), abdominal or lower abdominal pain, weight gain,
presence of fluid in the abdomen (ascites).
If you take more CLOMID than you should, inform your doctor or pharmacist, or go to the nearest
hospital.

If you forget to take CLOMID
Do not take a double dose to make up for a missed dose. Inform your doctor as
soon as you realize you have forgotten the dose.

If you stop taking CLOMID
Do not stop treatment with this medicine without consulting your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking CLOMID and immediately consult your doctor if:

• the following symptoms appear associated with allergic reactions: appearance of skin lesions such as blotches or widespread (urticaria), redness (erythema multiforme), inflammation (dermatitis), swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing;
• you experience abdominal pain, discomfort and a feeling of fullness, lower abdominal pain, weight gain, nausea, vomiting, diarrhea, liver changes, symptoms of mild ovarian hyperstimulation (see section 2 - “Warnings and precautions”);
• you experience progressive weight gain, severe abdominal pain, difficulty breathing (dyspnea), reduced urine output (oliguria) even severe and with kidney damage (renal failure), generalized swelling (anasarca), fluid in the abdomen (ascites) or in the chest (hydrothorax), low blood pressure (hypotension), ovarian hemorrhage, ovarian torsion, deep vein thrombosis symptoms of severe ovarian hyperstimulation;
• you experience visual problems such as blurred vision, flashing spots (photopsia), light sensitivity (photophobia), black spots in the visual field (scotomas), double vision (diplopia) and inflammation of the eye veins (periphlebitis) (see section 2 - “Warnings and precautions”).

The following side effects may occur:
Very common side effects(may affect more than 1 in 10 people)

• breast tenderness or pain, painful menstruation (dysmenorrhea), back pain;
• enlargement of the ovaries;
• pre-eclampsia, a condition that manifests with swelling and/or protein in the urine and/or high blood pressure;
• pregnancy complications, spontaneous abortion;
• mood swings, hot flashes, fatigue;
• abdominal distension and presence of gas in the abdomen (flatulence);
• alteration of the bromosulfonphthalene test (which evaluates liver function);
• dizziness;
• respiratory tract infections.

Common side effects(may affect up to 1 in 10 people)

• breast discomfort;
• vaginal bleeding (uterine or anovulatory hemorrhage);
• pain in the lower abdomen (adnexal pain);
• discomfort or abdominal pain, nausea, vomiting, diarrhea, difficulty evacuating (constipation), indigestion (dyspepsia), sore throat (oropharyngeal pain);
• headache, altered taste, decreased appetite;
• fetal death, embryos implanted outside the uterus (ectopic pregnancy);
• inability to carry a pregnancy in the uterus (cervical incompetence);
• HELLP syndrome, a condition characterized by decreased proteins, destruction of red blood cells, and increased liver enzymes during pregnancy;
• carbohydrate intolerance diagnosed for the first time during pregnancy (gestational diabetes);
• placenta inserted into the lower part of the uterus (placenta previa);
• labor before completion of the 37th week of pregnancy (preterm labor), rupture of membranes before 37 weeks of pregnancy (preterm premature rupture of membranes), placental detachment before 37 weeks (preterm placental abruption);
• postpartum bleeding, multiple pregnancy, postpartum depression;
• inflammation of the connective tissue surrounding the veins (periphlebitis).

Uncommon side effects(may affect up to 1 in 100 people)

• vertigo;
• weight gain;
• bruising on the skin (ecchymosis);
• bronchial inflammation (bronchitis);
• difficulty falling asleep (insomnia), tension;
• ovarian cysts due to bleeding (hemorrhagic ovarian cyst);
• abnormal and heavy uterine bleeding during menstruation (menorrhagia);
• frequent urination (pollakiuria) or excessive urination (polyuria).

Rare side effects(may affect up to 1 in 1,000 people)

• ovarian torsion, which manifests with abdominal pain, which becomes progressively more intense and severe often associated with nausea, vomiting;
• constipation;
• opacification of the lens located inside the eye (cataract).

Side effects with unknown frequency (frequency cannot be estimated on the basis of available data)

• blockage of the eye vein, inflammation of the optic nerve (optic neuritis);
• formation of blood clots in the veins, especially those of the legs (deep vein thrombosis);
• patchy hair loss (alopecia);
• skin reactions;
• mental disorders such as "psychosis" in some cases accompanied by ideas of persecution (paranoid psychosis), and feelings of anxiety, nervousness, irritability, depression;
• fast heartbeat (tachycardia), accentuated perception of heartbeat (palpitations);
• involuntary and uncontrolled movements of voluntary muscles (convulsions), sensation of numbness or tingling on the skin (paresthesia);
• disorders affecting mental functions, problems speaking, feeling faint (pre-syncope), feeling disoriented, loss of consciousness (syncope). stroke (cerebrovascular accident), formation of blood clots in the cerebral veins (cerebral thrombosis);
• increased levels of transaminases (liver enzymes) detected by blood tests;
• an excess of fats in the blood (hypertriglyceridemia);
• inflammation of the pancreas (pancreatitis);
• reduction in the thickness of the innermost layer of the uterus (reduced endometrial thickness);
• worsening of pre-existing endometriosis (presence of mucosa outside the uterus);
• tumors of the endocrine organs, ovarian tumors, skin tumors (melanoma).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store CLOMID

Keep this medicine out of the sight and reach of children.
No special storage precautions are required.
Do not use this medicine after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CLOMID contains
The active ingredient is: clomifene citrate.
One tablet contains 50 mg of clomifene citrate.
The other ingredients are: sucrose; lactose; soluble corn starch; magnesium stearate; corn starch; yellow iron oxide.

Description of the appearance of CLOMID and contents of the pack
CLOMID is available in packs of 10 tablets.

Marketing Authorisation Holder
BRUNO FARMACEUTICI S.p.A. Via delle Ande, 15 – 00144 – ROMA.

Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1 - 29016 Cortemaggiore (PC).
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1 – 03012 Anagni (FR)