Ulipristal Aristo 30 mg 1 film-coated tablet

Ulipristal Aristo is an emergency contraceptive

Ulipristal Aristo is a contraceptive used to prevent pregnancy after unprotected sexual intercourse or failure of the contraceptive method. For example:

• if you have had unprotected sexual intercourse;
• if your partner's condom broke, slipped or came off completely, or if you forgot to use a condom;
• if you have not taken your birth control pill as recommended.

The film-coated tablet should be taken as soon as possible after sexual intercourse, but no later than 5 days (120 hours) afterwards.
The reason for this is that the sooner it is taken after unprotected sexual intercourse, the higher the effectiveness.

This medicine is suitable for all women of childbearing age, including teenagers.

You can take the film-coated tablet at any time during the menstrual cycle.

Ulipristal Aristo is not effective if you are already pregnant.

If your period is late, there is a possibility that you are pregnant. If your period is late or if you experience symptoms of pregnancy (heavy breasts, morning sickness), contact a doctor or other healthcare professional before taking the film-coated tablet.
If you have unprotected sex after taking the film-coated tablet, you can still become pregnant.
You can become pregnant at any point in your cycle if you have unprotected sex.
Ulipristal Aristo is not suitable for regular contraception

If you are not using a regular method of contraception, talk to your doctor or nurse to choose a method that is right for you.

How Ulipristal Aristo works
Ulipristal Aristo contains the active ingredient ulipristal acetate, which changes the effect of the natural hormone progesterone, which is necessary for ovulation. As a result, this medicine delays ovulation. Emergency contraception is not effective in all cases: about 2 in 100 women who take this medicine will still become pregnant.

This medicine is a contraceptive used to prevent pregnancy from occurring. If you are already pregnant, it will not terminate the existing pregnancy.

Emergency contraceptives do not protect against sexually transmitted diseases.
Only condoms can protect you from sexually transmitted diseases. This medicine does not protect against HIV infection or other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, syphilis). If you have any concerns, contact your healthcare professional.

Contraindications

Do not take Ulipristal Aristo if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6).

Interactions

Other contraceptives and Ulipristal Aristo
This medicine may temporarily make regular hormonal contraceptives such as birth control pills and patches work. If you are currently taking hormonal contraceptives, continue to take them as usual after taking the film-coated tablet, but use condoms every time you have sex until your next period.
Do not use Ulipristal Aristo with other emergency contraceptives that contain levonorgestrel.
Taking/using them together could result in the effect of this medicine being reduced.

Taking Ulipristal Aristo with other medicines
Tell your doctor, pharmacist or other healthcare professional if you are taking or have recently taken any other medicines, including those obtained without a prescription or herbal medicines.

Some medicines can make Ulipristal Aristo less effective. If you have taken any of the following medicines within the last 4 weeks, Ulipristal Aristo may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraception, such as: B. a copper spiral:

• Medicines used to treat epilepsy (for example primidone, phenobarbital, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine and barbiturates)
• Medicines used to treat tuberculosis (for example rifampicin, rifabutin)
• Medicines used to treat HIV infection (ritonavir, efavirenz, nevirapine)
• Medicines used to treat fungal infections (griseofulvin)
• herbal medicines containing St. John's wort (Hypericum perforatum).

If you are taking (or have recently taken) any of the medicines listed above, talk to your doctor or pharmacist before taking Ulipristal Aristo.

Pregnancy, breast-feeding and fertility
Pregnancy
If your period is late, talk to your doctor, pharmacist or other healthcare professional before taking this medicine, or take a pregnancy test to make sure you are not already pregnant (see Warnings and Pregnancy section). Precautions").

This medicine is a contraceptive used to prevent pregnancy from occurring.
If you are already pregnant, taking it will not terminate the existing pregnancy.

If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy. However, you should definitely consult your doctor. As with any pregnancy, the doctor will examine whether the pregnancy is not outside the uterine cavity. This is particularly important if you experience severe abdominal (stomach) pain or bleeding or have previously had a pregnancy outside the uterus, surgery on the fallopian tubes, or a long-term (chronic) infection of the genitals.

If you become pregnant despite taking Ulipristal Aristo, ask your doctor to register your pregnancy in an official database. You can also enter this information yourself at http://www.ulipristal-pregnancy-registry.com. Your information will be treated confidentially, meaning no one will know that this information came from you. By sharing your information, you will help other women understand the safety and risks of Ulipristal Aristo during pregnancy.

Breast-feeding
If you are taking this medicine while you are breast-feeding, do not breast-feed your child for one week after taking this medicine. During this period, you are advised to express breast milk to stimulate and maintain milk production, but to dispose of it. The effects on the child of breast-feeding during the first week after taking this medicine are not known.

Fertility
This medicine has no effect on your future fertility. If you have unprotected sex after taking this medicine, it will not prevent a possible pregnancy. Therefore, it is important that you use condoms until your next period.
If you want to start or continue a regular method of contraception after taking this medicine, you can do so, but please use additional condoms until your next period.
Driving and using machines
Warning: This medicine may impair the ability to react and drive. Some women experience dizziness, drowsiness, blurred vision and/or loss of concentration after taking this medicine (see section 4: What side effects are possible?). If you experience these symptoms, you should not drive a motor vehicle or use machines.

Application

Always take this medicine exactly as described in this leaflet or exactly as your doctor, pharmacist or nurse has told you. Check with your doctor or pharmacist if you are unsure.

How to take the Ulipristal Aristo film-coated tablet

• Take one film-coated tablet as soon as possible and no more than 5 days (120 hours) after unprotected sexual intercourse or contraceptive failure. Do not delay taking the tablets.
• You can take the film-coated tablet at any time during your menstrual cycle.
• You can take the film-coated tablet at any time of the day and before, with or after a meal.
• If you are taking any of the medicines that can reduce the effectiveness of Ulipristal Aristo (see section 2 “Taking Ulipristal Aristo with other medicines”) or if you have taken/used any of these medicines in the past 4 weeks, Ulipristal may Aristo may be less effective for you. Before taking Ulipristal Aristo, talk to your doctor or pharmacist. Your doctor may prescribe another (non-hormonal) type of emergency contraception, such as a copper IUD.

If you vomit after taking Ulipristal Aristo
If you vomit (vomit) within 3 hours of taking the film-coated tablet, take a second film-coated tablet as soon as possible.

If you have sexual intercourse again after taking Ulipristal Aristo
If you have unprotected sexual intercourse again after taking the film-coated tablet, this will not prevent pregnancy. For this reason, use condoms every time you have sexual intercourse after taking the film-coated tablet until your next period.

If your next period is delayed after taking Ulipristal Aristo
After taking the film-coated tablet, it is normal for your next period to be delayed by a few days.
However, if your period is delayed for more than 7 days, if it is unusually light or unusually heavy, or if you experience symptoms such as abdominal (stomach) pain, breast tenderness, vomiting or nausea, there is a possibility that you may be pregnant are. In this case, take a pregnancy test immediately. If you are pregnant, be sure to consult your doctor (see “Pregnancy, breast-feeding and fertility” section).

Side effects

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

Some symptoms, such as breast tenderness and abdominal (stomach) pain, vomiting (vomiting), nausea (feeling sick), can also be signs of pregnancy. If you miss your period and experience the symptoms described after taking Ulipristal Aristo, take a pregnancy test (see “Pregnancy, breast-feeding and fertility” section).

Common side effects: may affect up to 1 in 10 people

• Nausea, abdominal (stomach) pain or discomfort in the stomach area, vomiting
• Menstrual pain, pelvic pain, breast tenderness
• Headaches, dizziness, mood swings
• Muscle pain, back pain, fatigue

Uncommon side effects: may affect up to 1 in 100 people

• Diarrhea, heartburn, flatulence, dry mouth
• abnormal or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal inflammation or discharge, decreased or increased libido
• Hot flashes
• Changes in appetite, emotional disturbances, anxiety, general physical restlessness, sleep disturbances, sleepiness, migraines, vision problems
• Influenza
• Acne, rash, itching
• Fever, chills, feeling sick

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

• Pain or itching in the genital area, pain during intercourse, shedding of an ovarian cyst, unusually light periods
• Loss of concentration, dizziness, shaking, confusion, fainting
• unusual feeling in the eyes, red eye, sensitivity to light
• dry throat, impaired sense of taste
• Urticaria, feeling thirsty
• Allergic reactions such as skin rash, hives or facial swelling

composition

The active ingredient is ulipristal acetate.
Each film-coated tablet contains 30 milligrams of ulipristal acetate.

The other ingredients are lactose monohydrate, pregelatinized starch (corn) and sodium starch glycolate, magnesium stearate, hypromellose (E464), hydroxypropylcellulose (E463), stearic acid (E570), talc (E553b), titanium dioxide (E171).

Interactions

Taking Tantum Grip with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even if they are non-prescription medicines.
It is particularly important to ask your doctor or pharmacist if you use the following medicines:

• Medicines that can accelerate (e.g. metoclopramide, domperidone to treat nausea and vomiting) or reduce/delay the absorption of paracetamol (e.g. cholestyramine, an agent used to lower blood cholesterol levels)
• Medicines to thin the blood or prevent blood clotting (e.g. warfarin and other coumarin preparations), as high doses of paracetamol can increase the risk of bleeding
• Medicines used to treat depression from a certain class of medicines (tricyclic antidepressants), other decongestants or medicines used to treat sleep disorders or epilepsy (barbiturates).
• Medicines that contain monoamine oxidase inhibitors (see also the section “Tantum Grip must not be used”)
• Medicines used to treat high blood pressure (beta-blockers) or vasodilators used to treat high blood pressure, leg pain due to vascular problems or Raynaud's syndrome)
• Medicines to treat heart failure (digoxin and cardiac glycosides)

Pregnancy and breast-feeding
The use of Tantum Grip during pregnancy or breast-feeding is not recommended. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Application

Dosage
Adults and children aged at least 12 years: 1 sachet every 4 to 6 hours, up to a maximum of 4 sachets in 24 hours.

Use in children
This medicine must not be used in children under 12 years of age.

Instructions for use
Dissolve 1 sachet in a glass of hot or cold water (approx. 150 ml) and sweeten as needed.
If your cold or flu symptoms do not improve after 3 days or get worse, contact your doctor or pharmacist.
Do not take Tantum Grip for more than 5 days.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Very rare: may affect up to 1 in 10,000 people

• Skin reactions

Not known: Frequency cannot be estimated from the available data

• allergic or hypersensitivity reactions (such as skin rashes)
• Blood disorders such as thrombocytopenia (reduction in blood platelets, which can lead to an increased tendency to bleeding or bruising), pancytopenia (reduction in white and red blood cells), agranulocytosis, leukopenia or neutropenia (reduction in white blood cells, which increases susceptibility to infections can)
• High blood pressure
• Headache
• Vomit
• Heartbeat (palpitations)
• acute pancreatitis (inflammation of the pancreas characterized by the appearance of sudden abdominal pain)
• Difficulty urinating (men only)

composition

Contents of one bag:
The active ingredients are: paracetamol 600 mg, phenylephrine hydrochloride 10 mg (equivalent to 8.2 mg phenylephrine).

The other ingredients are: sucrose, anhydrous citric acid, sodium citrate, corn starch, sodium cyclamate, saccharin sodium, ascorbic acid, colloidal silicon dioxide, lemon flavor, turmeric powder 5%, water-dispersible (curcumin E 100 + dried glucose syrup). See also section 2 “Tantum Grip contains sucrose, sodium and glucose”.

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