Lutinus 100 mg vaginal tablets Progesterone
What Lutinus Is And What It Is Used For
This medicine is available as a vaginal tablet, which contains the natural, female sex hormone progesterone.
Lutinus vag tab 100 mg is intended for women who need extra progesterone while undergoing treatment in an assisted reproduction program (ART).
Lutinus progesterone acts on the uterine lining and helps you get pregnant and maintain your pregnancy when you are being treated for infertility (involuntary infertility).
2. What You Need To Know Before Using Lutinus
Lutinus progesterone should only be used by women undergoing treatment in an assisted reproduction program (ART). The treatment is started on the day the eggs are taken out. Your doctor will inform you when treatment starts.
Do not use Lutinus 100 mg progesterone
- If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6)
- If you have abnormal vaginal bleeding, which has not been assessed by a doctor
- If you have a miscarriage and your doctor suspects that some tissue is still in the womb or suspects ectopic pregnancy (ectopic pregnancy)
- If you currently have or have had severe liver problems
- If you have known or suspected breast or genital cancer
- If you have or have had blood clots in your legs, lungs, eyes, or anywhere else in your body
- If you have porphyria (a group of congenital or acquired disorders of certain enzymes )
Warnings And Cautions
Take special care and tell your doctor immediately if you experience any of these symptoms during treatment or a few days after the last dose of lutinus 100 mg progesterone:
- Pain in the calves or chest
- Sudden shortness of breath
- Coughing up of blood, which may indicate clots in the legs, heart, or lungs
- Severe headache or vomiting
- Dizziness
- Lethargy or changes in vision or speech,
- Weakness or numbness in an arm or leg, which may indicate clots in the brain or eyes
- Aggravated depressive symptoms
Talk to your doctor before treatment with Lutinus progesterone side effects if you have or have had any of the following health problems:
- Epilepsy
- Migraine
- Asthma
- Impaired heart or kidney function
- Diabetes
Children
There is no relevant use of Lutinus in children.
Other Medicines And Lutinus Progesterone
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may effect of Lutinus 100 mg progesterone tablets. For example, carbamazepine, rifampicin, and herbal medicines containing St. John’s wort may reduce the effect, while products containing ketoconazole and vaginal products against fungal infections may alter the effect of progesterone.
Pregnancy And Breastfeeding
Lutinus can be used during the first trimester of pregnancy in women who need extra progesterone while undergoing treatment in an assisted reproduction program (ART).
The risk of congenital malformations, including genital malformations in boys or girls due to exposure to externally administered progesterone during pregnancy, has not been fully established.
This medicine should not be used during breastfeeding.
Driving And Using Machines
Lutinus vag tab 100 mg has a less or moderate effect on the ability to drive and use machines. It may cause drowsiness and/or dizziness. Therefore, vehicle drivers and machine users should be careful.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions of Lutinus progesterone side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lutinus 100 Mg How to use
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
The usual dose of Lutinus 100 mg, which is placed directly in the vagina three times a day, starting on the day the eggs are taken out. Treatment with Lutinus 100 mg progesterone should be continued for 30 days if pregnancy has been confirmed.
Instructions for use
Lutinus should be placed directly in the vagina using the supplied applicator (inserter).
- Detach a blister from the blister map by tearing along the perforation.
- To remove the foil on the back of the blister, start in the corner that has a printed arrow
- Unpack the applicator.
- Place a tablet in the designated place at the end of the applicator. The tablet should sit firmly and not fall out.
- The applicator with the tablet can be inserted into the vagina when you are standing, sitting, or lying on your back with your knees bent. Carefully insert the narrow end of the applicator high into the vagina.
- Press the plunger to release the tablet.
Take out the applicator and rinse it thoroughly in warm, running water, dry it with soft paper and save the applicator for later use.
Possible Lutinus Side Effects
Lutinus progesterone side effects
Like all medicines, Lutinus 100 mg progesterone can cause side effects, although not everybody gets them.
The most common Lutinus progesterone side effects are
- Headaches
- Vaginal disorders
- Uterine cramps
The following common side effect is affected between 1 and 10 in 100:
- Headache
- Tense abdomen (swollen abdomen)
- Abdominal pain
- Nausea
- Uterine cramps
The following uncommon side effects are affecting between 1 and 10 out of 1000 users:
- Dizziness
- Insomnia
- Diarrhea
- Constipation
- Urticaria (allergic skin rash)
- Rash
- Vaginal disorders (eg discomfort, burning sensation, discharge, dryness, and vaginal bleeding)
- Fungal infection of the vagina
- Breast disorders (eg chest pain, swollen and sore breasts)
- Itching in the abdomen
- Peripheral edema (swelling due to fluid retention)
The following Lutinus side effects have been reported since the medicine was marketed. No known frequency (can not be calculated from the available data):
- Fatigue
- Vomiting
- Allergic reactions
How to store Lutinus100 Mg Progesterone
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
- Store in the original package. Sensitive to light.
- No special storage instructions.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is progesterone.
- Each tablet contains lutinus 100 mg progesterone.
- The other ingredients are
- Colloidal anhydrous silica
- Lactose monohydrate
- Pregelatinized maize starch
- Povidone
- Adipic acid
- Sodium bicarbonate
- Sodium lauryl sulphate
- Magnesium stearate
What The Medicine Looks Like And The Contents Of The Pack
- This medicine is a vaginal tablet. It is a white to off-white flat, convex and oblong tablet debossed with “FPI” on one side and “100” on the other side.
- Pack size: 21 or 90 vaginal tablets, supplied with a polyethylene vaginal applicator.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Ferring Läkemedel AB
Box 4041, 203 11 Malmö
Manufacturer
Ferring GmbH
Wittland 11, D-24109 Kiel, Germany