Package leaflet: Information for the patient

CLOMID 50 mg tablets

Clomifene citrate
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CLOMID is and what it is used for
What you need to know before taking CLOMID
How to take CLOMID
Possible side effects
How to store CLOMID
Contents of the pack and other information

1. What CLOMID is and what it is used for

CLOMID contains clomifene citrate as the active substance, 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
ovulate properly.
Treatment with CLOMID must be initiated and carried out under strict medical supervision.

2. What you need to know before taking CLOMID

Do not take CLOMID if:

you are allergic to clomiphene citrate or to any of the other ingredients of this medicine (listed in section 6);
you have or have had liver problems;
you have vaginal bleeding (menometrorrhagia);
you have tumours that may worsen due to hormones (hormone-dependent);
you are pregnant (see section “Pregnancy and breastfeeding”);
you have an ovarian cyst not caused by polycystic ovary syndrome, as it could enlarge. Your 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 careful gynaecological examination and prescribe certain tests to check your liver function.
Talk to your doctor before taking CLOMID if you:

have fibroids in the uterus (benign tumours);
have ovarian cysts (fluid-filled sacs in the ovary);
have had bleeding episodes;
are in an advanced reproductive stage;
are experiencing premature menopause or have been told you are infertile, or have thyroid, adrenal disorders, or hyperprolactinaemia (increased blood levels of prolactin), which may affect ovarian function;
have stopped menstruating due to being underweight;
have a condition of the ovaries called “polycystic ovary syndrome”, a condition causing infertility, menstrual cycle irregularities, excessive hair growth, severe acne;
have hypertriglyceridaemia (excess fat in the blood) or a family history of hypertriglyceridaemia.

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

visual disturbances, usually temporary, such as blurred vision, flashing spots (photopsia), light sensitivity (photophobia), dark spots in the visual field (scotomata), double vision (diplopia), or inflammation of the eye veins (periphlebitis). In some cases, these symptoms may be permanent;
lower abdominal pain, abdominal pain and bloating and/or weight gain due to ovarian enlargement (ovarian hyperstimulation).

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

multiple pregnancy (e.g. twins);
ectopic pregnancy (in which the foetus develops outside the uterus);
possible fetal malformations or loss of the pregnancy. Any pregnancy may result in birth defects or spontaneous abortion. This may occur even if the pregnancy was not induced with CLOMID;
blood clotting disorders;
increased risk of developing ovarian tumours.

For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Other medicines and CLOMID
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those 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 might be.
If you are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
CLOMID may cause visual disturbances (see “Warnings and precautions”). If you experience these symptoms, avoid driving or operating machinery.
CLOMID contains lactose and sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take CLOMID

Take this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
When to start treatment

If you have not had your menstrual period in recent months, treatment can be started at any time.
If you have regular menstrual periods (even if induced by medications called progestogens), treatment should begin around the 5th day of the cycle.

Dosage
The recommended dose is 1 tablet per day, for 5 days ( first cycle ).
If the first treatment cycle is ineffective, your doctor will prescribe a new treatment cycle to be
started 30 days later. The recommended dose in the second cycle is 2 tablets per day (taken as a single dose), for 5 days.
If the second treatment cycle is also ineffective, your doctor may prescribe a third treatment cycle,
to be started 30 days later. The usual dose in the third cycle is 2 tablets per day (taken as a single dose), for 5 days.
If there is no response after 3 treatment cycles, your doctor may recommend specific tests to check for other possible fertility issues.
Method of administration
CLOMID is an oral medicine. Take the prescribed dose with water; do not chew or break the tablets. Do not exceed the recommended doses.
If you take more CLOMID than you should
you may experience the following symptoms: nausea and/or vomiting, hot flushes, blurred vision, dark spots in the visual field (scotomata), abdominal or lower abdominal pain, weight gain, fluid accumulation in the abdomen (ascites).
If you take more CLOMID than you should, inform your doctor or pharmacist, or go to the nearest hospital immediately.
If you forget to take CLOMID
Do not take a double dose to make up for the forgotten dose. Inform your doctor as soon as you realize you have missed a dose.
If you stop taking CLOMID
Do not stop treatment with this medicine without consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking CLOMID and consult your doctor immediately if:

the following symptoms of allergic reactions occur: skin lesions such as spotted or widespread rashes (urticaria), redness (erythema multiforme), inflammation (dermatitis), swelling (angioedema) of the face, eyes, lips, throat, accompanied by breathing difficulties;
you experience pain, discomfort, and a sensation of bloating in the abdomen, lower abdominal pain, weight gain, nausea, vomiting, diarrhoea, liver abnormalities, or symptoms of mild ovarian hyperstimulation (see section 2 - "Warnings and precautions");
you experience progressive weight gain, severe abdominal pain, breathing difficulties (dyspnoea), reduced urine output (oliguria), even severe with kidney damage (renal failure), generalized swelling (anasarca), fluid accumulation in the abdomen (ascites) or in the chest (hydrothorax), low blood pressure (hypotension), ovarian haemorrhage, ovarian torsion, or symptoms of severe ovarian hyperstimulation;
you experience visual disturbances such as blurred vision, flashing spots (photopsia), light sensitivity (photophobia), black spots in the visual field (scotomas), double vision (diplopia), or 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 (dysmenorrhoea), back pain;
ovarian enlargement;
pre-eclampsia, a condition characterized by swelling and/or presence of protein in the urine and/or high blood pressure;
pregnancy complications, spontaneous abortion;
mood swings, hot flushes, fatigue;
abdominal distension and gas in the abdomen (flatulence);
altered bromsulphthalein test (a test assessing liver function);
dizziness;
respiratory tract infections.

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

breast discomfort;
vaginal bleeding (uterine or anovulatory haemorrhage);
pain in the lower abdomen (pain in uterine adnexa);
abdominal discomfort or pain, nausea, vomiting, diarrhoea, difficulty in defecation (constipation), indigestion (dyspepsia), sore throat (oropharyngeal pain);
headache, altered taste, decreased appetite;
fetal death, embryos implanted outside the uterus (ectopic pregnancy);
inability to retain a pregnancy in the uterus (cervical incompetence);
HELLP syndrome, a condition characterized by decreased platelet count, destruction of red blood cells, and increased liver enzymes during pregnancy;
carbohydrate intolerance first diagnosed during pregnancy (gestational diabetes);
placenta implanted in the lower part of the uterus (placenta praevia);
labour before completion of the 37th week of pregnancy (preterm labour), rupture of membranes before the 37th week of pregnancy (preterm premature rupture of membranes), placental abruption before the 37th week (preterm abruption);
bleeding after childbirth, multiple pregnancy, postpartum depression;
inflammation of the connective tissue surrounding the veins (periphlebitis).

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

dizziness;
weight gain;
skin bruising (ecchymosis);
inflammation of the bronchi (bronchitis);
difficulty falling asleep (insomnia), tension;
ovarian cyst due to bleeding (haemorrhagic ovarian cyst);
abnormal and excessive uterine bleeding during menstruation (menorrhagia);
frequent urination (pollakiuria) or excessive urine output (polyuria).

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

ovarian torsion, presenting as abdominal pain that becomes increasingly severe and intense, often associated with nausea and vomiting;
constipation;
clouding of the lens inside the eye (cataract).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

blockage of the eye vein, inflammation of the optic nerve (optic neuritis);
formation of blood clots in veins, particularly in the legs (deep vein thrombosis);
patchy hair loss (alopecia);
skin reactions;
mental disorders such as "psychosis", in some cases accompanied by delusions of persecution (paranoid psychosis), as well as feelings of anxiety, nervousness, irritability, depression;
increased heart rate (tachycardia), heightened awareness of heartbeat (palpitations);
involuntary and uncontrolled movements of voluntary muscles (convulsions), numbness or tingling sensations on the skin (paraesthesia);
disturbances in mental functions, speech difficulties, feeling of fainting (pre-syncope), disorientation, loss of consciousness (syncope), stroke (cerebrovascular accident), formation of blood clots in cerebral veins (cerebral thrombosis);
increased levels of transaminases (liver enzymes) detected in blood tests;
excess fat in the blood (hypertriglyceridaemia);
inflammation of the pancreas (pancreatitis);
reduced thickness of the innermost layer of the uterus (reduced endometrial thickness);
worsening of pre-existing endometriosis (presence of endometrial tissue outside the uterus);
tumours of endocrine organs, ovarian tumours, skin tumours (melanoma).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the label. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

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

Marketing Authorization Holder
BRUNO FARMACEUTICI S.p.A., Via delle Ande, 15 – 00144 – ROME.

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)