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Information Tor the user

Period Pain Relief 250 mg Gastro-Resistant Tablets (Naproxen)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat period pain. However, you still need to take it carefully to get the best results from it.

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Naproxen, which belongs to a group of medicines called non-steroidal anti-inflammatory medicines, which act to relieve pain and reduce swelling.

It can be used to treat period pain and relieve associated cramps in adolescents and women, aged 15 to 50 years.

Before you take this medicine

This medicine can be taken by adolescents and women, aged 15 to 50 years. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

XDo not take:

•    If you have a stomach ulcer, perforation or bleeding, or have had one twice or more in the past

•    If you have had a perforation or a bleeding stomach after taking a non-steroidal anti-inflammatory medicine (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)

•    If you are allergic to naproxen or any other ingredients of the product (see "What is in this medicine")

•    If you are allergic to aspirin or other non-steroidal anti-inflammatory medicines (you have ever had asthma, a runny nose, swellings inside the nose (nasal polyps), itchy skin or swelling of the lips, face or throat after taking these medicines)

•    If you are taking other non-steroidal anti-inflammatory medicines (this includes aspirin, ibuprofen and medicines called cox 2 inhibitors)

•    If you have severe heart, kidney or liver failure

•    If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains lactose)

•    If you are pregnant

•    If you are breastfeeding, unless your doctor tells you to

! Talk to your pharmacist or doctor:

•    If you have asthma, a history of asthma or other allergic disease, bowel problems, Crohn’s disease, ulcerative colitis

•    If you have other heart, kidney or liver problems (see above)

•    If you have a blood clotting disorder, or any other problems with your blood

•    If you started having period pain more than a year after your first period

•    If you have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)

•    If you are elderly - you may get more side effects (see back of leaflet)

•    If you are taking any other painkillers, steroids, or receiving regular treatment from your doctor

•    If you have had a stroke, or have heart problems, high blood pressure, diabetes, high cholesterol, or you smoke - see ‘Risk of heart attack or stroke’ in 'Other important information'

Other important information

Risk of heart attack or stroke:

Naproxen may increase the risk if you take large amounts for a long time. The risk is small. Take the lowest amount for the shortest possible time to reduce this risk. Driving and using machines: This medicine may make you feel dizzy, depressed, sleepy, tired, or make it difficult to sleep. It may also affect your vision. You should not drive or use machines until you are sure you are not affected.

If you are having any medical tests:

This medicine may mask the symptoms of swelling (inflammation) and fever and interfere with the results of certain blood and urine tests. If you are having any tests tell the doctor or hospital staff that you are taking this medicine.

Women of childbearing age: If you take this medicine, it may reduce your ability to become pregnant. This effect will be reversed when you stop the medicine.

If you take other medicines

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Other painkillers

•    Medicines to thin your blood (e.g. warfarin, heparin)

•    Mifepristone (for termination of pregnancy) - do not take naproxen if you have taken mifepristone in the last 12 days

•    Water tablets (diuretics), or medicines to treat high blood pressure, medicines for heart problems

•    Corticosteroids (for pain and swelling)

•    Lithium (for bipolar disorder)

•    Methotrexate (for cancer, psoriasis, or rheumatism)

•    Zidovudine (for HIV infection)

•    Quinolone antibiotics (for infections)

•    Sulphonamide antibiotics (for treating or preventing serious infections)

•    Medicines to treat type II diabetes

•    Dantrolene (used to relax muscles)

•    Medicines for depression

•    Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)

•    Probenecid (to prevent gout)

•    Antacids (for indigestion and heartburn), colestyramine (to reduce blood fat levels)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

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/How to take this medicine

Check the foil is not broken before first use. If it is, do not take that tablet.

Age

How many to take and how often

Adolescent girls and women, aged 15 to 50 years	First day of pain: Two tablets to start with. Then, one more tablet after 6 to 8 hours, if you need to. Second and third day: One tablet every 6 to 8 hours, if you need to.
	Don’t lake more than 3 tablets in 24 hours.
Take the lowest amount for the shortest possible time to relieve your symptoms.

Swallow each tablet whole with water, preferably with or after food. Do not chew, cut or crush the tablets.

Do not give to children under 15 years. Do not take more than the amount recommended above.

Do not take this medicine for more than 3 days in any one period (menstrual cycle), unless your doctor tells you to.

If your symptoms do not go away within 3 days talk to your doctor.

f If you take too many tablets: Go to

your nearest hospital casualty department or talk to a doctor straight away. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these serious side effects, stop taking the tablets. See a doctor at once:

•    You are sick and it contains blood or dark particles that look like coffee grounds

•    Pass blood in your stools or pass black tarry stools

•    Stomach problems including pain, indigestion or heartburn

•    Severe stomach pain, which may reach through to the back. This may be a sign of pancreatitis, which is very rare

•    Allergic reactions such as skin rash (which can sometimes be severe and include peeling and blistering of the skin), swelling of the face, neck or throat, worsening of asthma, difficulty in breathing, cough, night time sweats

•    Stiff neck, fever, disorientation (symptoms of meningitis) - this is more likely if your doctor has told you that you have an auto-immune disease such as SLE

•    Kidney problems, which may lead to kidney failure (you may have blood in your urine, discoloured urine, pain in your lower back)

•    Liver problems (which may cause yellow skin or eyes or abnormal results from liver function tests)

These other effects are less serious. If they bother you talk to a pharmacist:

•    Feeling thirsty, feeling sick, being sick, changes to the stomach, mouth or digestive track lining (swelling or ulcers)

•    Diarrhoea, wind, constipation, worsening of colitis or Crohn’s disease

•    Headache, light headiness, feeling unsteady on your feet (vertigo), dizziness, fits

•    Feeling depressed, confusion, difficulty concentrating

•    Drowsiness, difficulty sleeping, abnormal dreams, hallucinations

•    Raised levels of potassium in your blood, palpitations (you may feel a flutter or thumping sensation in your chest), heart failure

•    High blood pressure, swelling of blood vessels walls

•    Fluid retention, which may cause swelling of the limbs

•    Swelling of the lung wall, fluid on the lung

•    Problems with vision, swelling of the optic nerve or back of the eye

•    Hair loss, sensitivity to light, itchy, red raised skin rash, a rash with eruptions of pus

•    Bruising, or bruising under the skin

•    Tingling, pins and needles, muscle pain or weakness

•    Feeling unwell, exhausted, fever, sweating

•    Ringing in the ears, hearing problems