Crinone Vaginal Gel 8% ingredient progesterone 15 Applicators

USAGE INSTRUCTIONS

Active substance: Progesterone

Each application of gel is 90 mg progesterone dose.

Excipients: Glycerin, mild liquid paraffin, hydrogenated palm oil glyceride, carbopol, sorbic acid, polycarbophil, sodium hydroxide, pure water

Before you start using this medicine, please read this INSTRUCTIONS carefully because it contains important information for you.

- Keep these instructions for use. You can need to read again.

- If you have other questions, please talk your doctor or pharmacist.

- This medicine has been prescribed to you personally, please do not give to others.

- When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

- Obey exactly what is written in this instruction. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is CRINONE and what is it used for?

2. Cautions before using CRINONE

3. How to use CRINONE

4. What are the possible side effects?

5. Heading CRINONE is

included.

1. What is CRINONE and what is it used for?

CRINONE is in the form of a vaginal gel and contains a hormone called progesterone. When the gel is given to your vagina, progesterone is slowly released into your bloodstream throughout the day.

Each is presented in a package containing 15 vaginal applicators, allowing for the administration of 90 mg of progesterone.

Areas of use

Crinone is used to give you additional progesterone in the treatment of infertility if you have the wrong progesterone levels in your period or during the assisted reproduction procedure. This helps you get pregnant. You may also be asked to continue using Crinone to support your new pregnancy.

2. Before using CRINONE In the

treatment of fertility disorders, you and your partner's reproductive ability should be evaluated before starting treatment with your doctor.

DO NOT use CRINONE

if:

If you have a known allergy against any of the ingredients in crınone the content

ofunknown cause, if you have bleeding related to women's health,

if you have porphyria (which can be passed from parents to children, porphyrins (chemical substances found in the body) segments failure status)

If the cancer you suspect that you know your breasts to your or genitals or not,

have had ahave had a blood clot due to swollen vessels (thrombophlebitis), a blocked blood vessel (thromboembolic disorder), or a stroke

liver disorder or disease, if you are

if youpregnant and your baby has died (impaired pregnancy) if you

Do not use CRINONE.

If you are unsure, talk to your doctor, nurse or pharmacist before using this medicine.

CAREFULLY USE CRINONE infollowing cases: If

any of theany of the following apply to you, talk to your doctor or pharmacist before using CRINONE. They may want to follow you closely during your treatment. If;

If you have kidney problems, have

heart problems or diabetes (diabetes), have

asthma, have

epilepsy (epilepsy), or have frequent migraines, you

have had depression.

Tell your doctor if you experience unexpected bleeding. So they can investigate the cause.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

CRINONE is applied in the first months of pregnancy in women who want to become pregnant through an ART (Assisted Reproductive Technique) method.

The use of CRINONE is not approved for use at the risk of repeated low or low.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Progestogens do not breastfeed while using this medicine because they pass milk.

use of

Use of machinery and machinery Be careful if you are using dangerous machinery and / or motor vehicles because of excessive fatigue and drowsiness due to theCRINONE.

Use with other medications If you dowith other drugs, but use

not have a known interactionCRINONE with other vaginally administered drugs, this application should be before or after a 6 hour period of CRINONE administration. Even after a few days of use, small, white globules may appear in the vaginal secretion, possibly due to gel deposition. If you are given an antifungal treatment (vaginally), you will be advised to switch to an oral treatment.

Please inform your doctor or pharmacist if you are currently using or have recently used any prescription or non-prescription medicine.

Important information about some of the ingredients in CRINONE

This drug contains sorbic acid. May cause local skin reactions (such as contact dermatitis) or vaginal irritation.

3. How to use CRINONE

Always use CRINONE as instructed by your doctor. If you are unsure, talk to your doctor or pharmacist.

Instructions for proper use and dose / frequency of administration:

Place the content of a CRINONE applicator (application tool) into your vagina every day after you tell your doctor you have finished or from day 18 to 21 of your menstrual cycle. (The first day of your menstrual cycle is the day your menstruation begins.) When

used during in-vitro fertilization, place the contents of a CRINONE applicator into your vagina every day, preferably in the morning, from the day of embryo transfer. After you confirm that the tests are pregnant, you may be asked to continue using CRINONE to support the new pregnancy - for a total of 30 days.

The applicator was designed to provide 1,125 grams of gel containing exactly 90 mg of progesterone. A small amount of gel is expected to remain in the applicator. Since you will have all the medication you need, the applicator containing this remaining part can be discarded.

Application path and method:

CRINONE is used by applying the vagina with the ready-to-use applicator provided in the package.

If your doctor has not made another suggestion, it is recommended to use a single dose per day in the morning.

There is no need to rest after using. On the contrary, daily activitiesthe distribution of the drug

will positively affect, therefore the likelihood of accumulation in the vagina will be reduced.

It is applied without damaging the tissue with its applicator specially designed for vaginal use.

Before applying CRINONE to yourself, please read the following instructions carefully: Your

applicator's appearance:

Preparing your:

applicatorRemove the applicator from its sealed package.bend and pull the opened head at this stage

Do not remove the.

Caution: To apply at high altitudes (above 762 meters), makeat theend of the thick end

a hole with the needleflat. This willininside and outside of the applicator at high altitudes

regulate the differencethe air pressure between the. It will not affect the amount of dose to be taken.

* Grasp the thick end of the applicator.allowcontents to accumulate in the fine tip

Shake the thermometer as if shaking by holding it downward tothe.

Opening the applicator:

Placing the applicator:

1. Air compartment

2. Flat side of the

thick tip 3. Thick tip

4. Thin end

5. Cover

Now,the cover on the thin end of the applicator by twisting and unrolling the cap

open.gelbefore you start to use

air baffle at this stage to prevent thefrom leaking outit

Do not tighten the.

Place the applicator in the sitting position oryour knees bent

lying on your back with.thin end of the applicator into the

Gentlyvagina until your hands touch your body

insert the.

thickthe applicator to push the gel into the vagina

Tighten the air baffle at theend of.

Caution: To apply at high altitudes, place your thumb

or fingerflat end of the bulging at the thick end

over the hole in the.

5 After using your applicator:

Remove the applicator and discard it. It is not important to have a small amount of gel in the applicator. You have enough dose.

CRINONE gel may remain in your vagina for several days. During this time, you may have beige to brownish clustered or fuzzy white currents. It is not a situation to worry about.

Different age groups:

Use in:

childrenCRINONE is not intended for use in children.

Use in the elderly:

CRINONE is not intended for use in the elderly.

Special Use Cases:

Renal / liver failure:

CRINONE should not be used in liver failure. In patients with renal impairment should be used with caution.

Talk to your doctor or pharmacist if you have an impression that CRINONE is too strong or too weak.

If you use more CRINONE than you should:

Talk to a doctor or pharmacist if you have used more than you should use from CRINONE.

Do not apply more than the recommended daily dose. No cases of overdose associated with CRINONE have been reported.

If you forget to use CRINONE:

Remember that you forgot a CRINONE dose, apply that dose immediately and continue the practice according to the previous program.

Do not double-dose to compensate for forgotten doses.

Effects after cessation of treatment with CRINONE If

you stop taking your medication without consulting your doctor, you will not be able to respond to your treatment.

4. What are the possible side effects?

Like all medicines, CRINONE may have side effects in people who are sensitive to the substances contained in its contents.

Hypersensitivity reactions have generally been reported as skin redness and other mild administration site reactions.

CRINONE is generally well tolerated. In clinical trials, the following side effects have been reported during CRINONE therapy.

Side effects that can be seen are classified as shown in the following categories:

Very common: It can be seen in at least one of 10 patients.

Common: Less than one in 10 patients, but more than one in 100 patients.

Uncommon: Less than one in 100 patients, but more than one in 1,000 patients. Rare: less than one in 1,000 patients, more than one in 10,000 patients.

Very rare: less than one in 10,000 patients.

Unknown: Unpredictable from available data.

Very common

headache, depression (depression), mood variability, irritability, drowsiness,

fatigue, pelvic pain, breast swelling / tenderness

Common

Urinary tract infections,

forgetfulness, dizziness,

vomiting, constipation, diarrhea, bloating, nausea

genitals itching , throttle in the organ

, cramps in the legs, leg and joint pain

Painful sexual intercourse, nocturnal urination, cystitis (bladder inflammation)

Back pain, abdominal pain, discharge from the sexual organ, increase in the discharge from the sexual organ, allergy, decreased sexual desire , dryness in the genitals

Uncommon

bleeding under the skin (bruising; purpura), anemia

Inflammation, pharyngitis (inflammation of the air in the bones of the face), sinusitis (inflammation of air voids in the facial bones), upper respiratory tract Inflammation

, dry mouth, increased sweating

Migraine, chills, insomnia , hypersensitivity to stimuli

Eye dry, konj oncivitis (a kind of eye inflammation)

Fainting,

asthma, shortness of breath, breast growth, hyperventilation (abnormally fast and deep breathing), coldness

Indigestion, burp, toothache, stomach pain

Rash, skin discoloration, skin disorders, urticaria (hives) ), dandruff, acne (acne-like skin rash)

Painful urination, frequent urination, leukore (white discharge)

Allergic reaction, decreased appetite, weakness, edema, facial edema, hot flashes, fever, immunity, bleeding from the sexual organ / spotting, premenstrual syndrome (premenstrual tension syndrome), painful menstruation, lactation (such as breast milk), flu-like symptoms

Very rare

Benign cyst

Muscle pain

Post-marketing reports In

addition, intermenstrual bleeding (bleeding / spotting between two menstrual periods), hypersensitivity reactions to the genital organs, usually manifesting itself as itching in the skin. e other light application site reactions have been reported after marketing.

The relationship of CRINONE therapy with all the above events is not known. Most undesirable effects are mild and transient and disappear with continued CRINONE therapy.

Report side effectsside effects that are

If you experience anyincluded in the instructions for use or not, talk to your doctor, pharmacist or nurse. Also located on the side effects www.titck.gov.t site you encounter "Drug Side Impact Statement" by clicking on the icon or 0800314 00 08 number of side effects by calling the notification line Turkey Pharmacovigilance Center (TÜFAM) 'What do you notice. By informing you of any side effects, you will contribute to further information on the safety of the drug you are using.