Ultravana Period Pain Relief Ultravana Period Pain Relief

Talk to your doctor or pharmacist before taking Ultravana Period Pain Relief if you:

• are on a low potassium diet, as this product contains potassium sorbate – high blood levels of potassium can cause stomach upset and diarrhoea.

• have a history of gastrointestinal disease, e.g. ulcerative colitis, Crohn’s disease

• are elderly or frail, you have a higher risk of getting side effects, especially of the stomach – if you experience any unusual symptoms from the stomach, you must tell your doctor about it

• have or have had high blood pressure, a stroke or any heart, liver or kidney problems - if you have kidney or liver problems you should only take Ultravana Period PainRelief under the supervision of your doctor, for monitoring of your kidney or liver function - medicines such as naproxen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment.

Do not exceed the recommended dose or duration of treatment.

• have asthma, diabetes, high cholesterol

• are a smoker

• drink alcohol

• have systemic lupus erythematosus or other connective tissue disorders

• have Stevens-Johnson syndrome or toxic epidermal necrolysis (severe skin problems)

• have any blood clotting disorders

• first experienced period pain more than a year after starting your periods

• are a woman trying to become pregnant or undergoing investigation of infertility – naproxen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that naproxen, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant

• Ultravana Period Pain Relief may hide the symptoms of an infection.

When taking Ultravana Period Pain Relief, inflammation in your kidney may occur. Signs and symptoms may include decreased volume of urine or blood in your urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report such signs to the treating physician.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines obtained with or without a prescription

Especially:

• other non-steroidal anti-inflammatory drugs (NSAIDs), e.g. COX II inhibitors (used for pain and

inflammation)

• aspirin/acetylsalicylic acid to prevent blood clots

• antacids (to treat heartburn)

• medicines to treat high blood pressure including angiotensin II receptor antagonists or ACE inhibitors, such as captopril, ramipril or propranolol

• diuretics (‘water tablets’), such as furosemide

• cardiac glycosides (for heart failure), such as digoxin

• lithium (used for some mental health problems)

• methotrexate (to treat some cancers)

• ciclosporin, tacrolimus (to suppress the immune system)

• mifepristone (used for termination of pregnancy) –

Ultravana Period Pain Relief should not be taken within 8-12 days of taking mifepristone

• corticosteroids (used in many different diseases), such as prednisolone

• medicines which thin the blood or prevent blood clotting, such as warfarin

• SSRI antidepressants (for depression), such as fluoxetine

• medicines used to treat Type 2 diabetes, such as sulphonylurea

• quinolone antibiotics (to treat bacterial infections), such as ciprofloxacin

• probenecid (used for gout)

• hydantoins (in epilepsy), such as phenytoin

• zidovudine (anti-viral)

• colestyramine (for high cholesterol) – take naproxen 1 hour before or 4 to 6 hours after colestyramine to avoid interference with absorption.

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Stop taking Ultravana Period Pain Relief and tell a doctor or pharmacist, or go to your nearest hospital casualty department immediately if you experience any of the following serious side effects (not known, frequency cannot be estimated from the available data).

•  An allergic reaction: swelling of the face, mouth, tongue, airways or body; difficulty breathing or wheezing, coughing up blood; skin reactions including hives (pale/red raised skin with severe itching), itchy skin rash, blood spots, bruising or discolouring of the skin, raised purple rashes, red skin patches, bumpy rashes, blisters, dermatitis (skin shedding, itching, swelling).

•  Severe skin rash with flushing, blisters or ulcers (Stevens-Johnson syndrome); a severe rash with reddening, peeling and swelling of the skin that resembles burns (toxic epidermal necrolysis); blistering of skin when exposed to sunlight (pseudoporphyria).

•  Heart attack or stroke.

•  Serious stomach problems: ulcer or inflammation in the stomach or gut (causing indigestion, heartburn, pains in your stomach, feeling or being sick); worsening of colitis and Crohn’s disease (pain, diarrhoea, vomiting, weight loss); black tarry looking stools (signs of bleeding and perforation of the stomach and intestines); vomit any blood or dark particles that look like coffee grounds; pancreatitis (causing fever, stomach pain, sickness).

•  Sudden shortness of breath, chest pain, nausea, these could be signs of hyperkalaemia.

•  Meningitis (symptoms include a stiff neck, headache, feeling or being sick, fever, sensitivity to bright light and confusion).

•  Liver problems including yellowing of the skin or whites of your eyes (jaundice); feeling tired, loss of appetite, feeling or being sick, pale coloured stools (hepatitis shown in blood tests).

Pregnancy and breastfeeding

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.

Do not take Ultravana Period Pain Relief if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected.

You should not take Ultravana Period Pain Relief during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, naproxen can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow whole with water, with or after food. Do not crush or chew the tablets.

You should make sure that you have enough to drink (stay well hydrated) when you are taking Ultravana Period Pain Relief. This is particularly important for people who have problems with their kidneys.

You should take the lowest effective dose for the shortest amount of time, to control your symptoms.

This will reduce any side effects you may experience.

First day of treatment

Initially take two tablets (500mg) then if needed, one tablet (250mg) after 6-8 hours.

If needed, take one tablet (250mg) every 6-8 hours.

Do not take more than the maximum dose of three tablets a day for longer than three days during each month (menstrual cycle).

It is important not to take too many tablets. Contact your doctor, pharmacist or nearest hospital casualty department immediately if you have taken more tablets than you should. Symptoms of an overdose are headache, heartburn, feeling or being sick, stomach pain or bleeding, diarrhoea, disorientation, excitation, drowsiness, dizziness, ringing in the ears, fainting.

If you forget to take a tablet, take your forgotten dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

The active substance (the ingredient that makes the medicine work) is naproxen.

Each tablet contains 250 mg of the active substance.

•  The tablet is gastro-resistant, which means that it is covered with a coating which stops the tablet dissolving in the stomach, so that the naproxen is released further down in your gut.

•  The other ingredients are methacrylic acid-ethylacrylate copolymer (1:1), lactose, magnesium stearate, maize starch, crospovidone, propylene glycol, sodium hydroxide, triethyl citrate, titanium dioxide (E171), potassium sorbate (E202), sodium citrate (E331), xanthan gum (E415), hydroxypropyl cellulose (E463), purified talc (E553), beeswax.