Duinum

Duinum

clomifene

Manufacturer:

Medochemie

Distributor:

F.C.P.

Marketer:

B.Grimm Pharma
Full Prescribing Info
Contents
Clomiphene citrate.
Description
The tablets are white, round, flat, scored, embossed "D", with 9.5 mm diameter.
The active substance is clomifene citrate.
Excipients/Inactive Ingredients: The other ingredients are Citric acid, maize starch, crospovidone, sucrose, colloidal silicon dioxide and magnesium stearate.
Action
DUINUM contains a medicine called clomifene citrate. This belongs to a group of medicines called ovulation stimulants. It works by stimulating the release of eggs from the ovary (ovulation).
Indications/Uses
DUINUM is used for some types of infertility, in women who are not ovulating properly.
Dosage/Direction for Use
HOW TO TAKE DUINUM: Always take DUINUM exactly as the doctor has told. The patient should check with the doctor or pharmacist if she is not sure.
Take this medicine by mouth. Swallow the tablets whole with a drink of water. Do not crush or chew the tablets. Do not take more than two tablets in one day. Do not take the tablets for more than five days at a time. If the patient feels the effect of the medicine is not working, she should not change the dose on her own, but ask the doctor.
DUINUM is for adult women only. The doctor will tell the patient when in her menstrual cycle to start taking the tablets. For the first course of treatment, take one tablet a day for five days. If the patient has a period after the first course of treatment, the doctor will increase the dose to two tablets a day for five days. The patient should start this second course at least 30 days after the first course. The patient will not usually take more than three courses of treatment. If ovulation does not happen after three courses, talk to the doctor.
If the patient forgets to take DUINUM: If the patient forgets a dose, talk to the doctor as she may need to change her treatment cycle. Do not take a double dose to make up for a forgotten tablet.
If the patient stops taking using DUINUM: Keep taking DUINUM until the doctor tells the patient to stop. If the patient stops, the treatment may not work.
If the patient has any further questions on the use of this product, ask the doctor or pharmacist.
Overdosage
If the patient takes more DUINUM than she should: If the patient takes more DUINUM than she should, tell a doctor or go to a hospital casualty department straightaway. Take the medicine pack. This is so the doctor knows what the patient had taken. The patient is likely to get over-stimulation of her ovary.
Contraindications
Do not take DUINUM: If the patient is allergic (hypersensitive) to clomifene or any of the other ingredients of DUINUM; signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue; if the patient has or ever had liver disease; if the patient has unusual menstrual bleeding where the cause is not known; if the patient has a cyst on her ovary; if the patient is pregnant. The patient should have a test to make sure she is not pregnant before she takes clomifene.
Special Precautions
Take special care with DUINUM and talk to the doctor about the risk of: Becoming pregnant with more than one child at the same time (multiple pregnancies).
Pregnancies where the baby grows outside of the womb (ectopic).
Increased risk of cancer in the ovaries.
Any pregnancy could lead to birth defects or miscarriage. This can happen even if the patient is not taking clomifene. The patient should talk to the doctor about the possible risks before she takes clomifene.
Take special care with DUINUM and check with the doctor or pharmacist before taking the medicine if: The patient is having an early menopause or has been told she is infertile; the patient has 'fibroids' in her womb; the patient has 'polycystic' ovaries; ovaries are swollen.
The patient should check for any other causes of fertility problems before starting treatment with DUINUM.
If the patient is not sure if any of the previously mentioned texts applies to her, talk to the doctor or pharmacist before taking DUINUM.
Driving and using machines: The patient may notice problems with her eyesight such as blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use In Pregnancy & Lactation
Pregnancy and breast-feeding: Do not take this medicine if the patient is pregnant or thinks she may be pregnant.
Talk to the doctor before taking this medicine if the patient is breast-feeding or planning to breast-feed.
DUINUM can lower the amount of milk produced.
Ask the doctor or pharmacist for advice before taking any medicine.
Adverse Reactions
Like all medicines, DUINUM can cause side effects, although not everybody gets them.
Stop taking DUINUM and see the doctor or go to a hospital straight away if: The patient has an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
The patients has numbness, weakness or paralysis on one side of the body, slurred speech, sudden blurred vision, confusion or unsteadiness. These could be signs of a stroke.
Stop taking DUINUM and see a doctor straight away if the patient notices any of the following serious side effects - the patient may need urgent medical treatment: Over-stimulation of the ovary. This can lead to pain in the pelvis, stomach or calf, swelling or feeling bloated, passing less urine, difficulty in breathing or an increase in weight. If this happens, the doctor may lower the dose of DUINUM.
Blurring of vision or spots or flashes in front of the eyes.
Liver problems that may cause the eyes or skin to go yellow (jaundice).
Sudden and severe headaches.
Mental illness such as 'psychosis'.
Tell the doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: Increased pain with periods, heavy periods or bleeding between periods.
Pain in the lower part of the stomach. This could be a sign of endometriosis or worsening of endometriosis, ovarian cancer or enlarged ovaries.
Cloudy lenses in the eye (cataracts).
Fits, feeling faint, dis-orientated or more tense than normal. Also, balance problems or feeling dizzy (vertigo).
Feeling tired or difficulty in sleeping (insomnia), depression or change in moods or behavior.
Speech problems.
Skin rash or itching.
Feeling or being sick.
Flushing of the skin.
Headaches.
Swelling of the face, around the eyes, lips or tongue.
Painful breasts.
Hair loss or thinning.
Talk to the doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days or if the patient notices any side effects not listed in this monograph.
If any of the side effects gets serious or lasts longer than a few days, or if the patient notices any side effects not listed in this monograph, tell the doctor or pharmacist.
Drug Interactions
Taking other medicines: Tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription. This is because DUINUM can affect the way some other medicines work. Also some medicines can affect the way DUINUM works.
Storage
Store below 25°C in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GB02 - clomifene ; Belongs to the class of synthetic agents used as ovulation stimulants.
Presentation/Packing
Form
Duinum tab 50 mg
Packing/Price
1 × 10's;3 × 10's
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