NURULIN DUO

PACKAGE LEAFLET: INFORMATION FOR THE USER NURULIN DUO 500 mg / 200 mg tablets paracetamol/ ibuprofen Read all of this the leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as you have been told by your pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, ask your pharmacist.
• If you get any adverse reactions, please tell your doctor or pharmacist. This includes any possible adverse reactions not listed in this leaflet.
• Do not take this product for more than three days or if the symptoms worsen unless specifically advised by your doctor.

What is in this leaflet:

1. What NURULIN DUO is and what it is used for.
2. What you should know before taking NURULIN DUO.
3. How to take NURULIN DUO
4. Possible adverse reactions.
5. How to store NURULIN DUO
6. Contents of the package and further information.

1. What NURULIN DUO is and what it is used for NURULIN DUO contains two active ingredients paracetamol 500 mg and ibuprofen 200 mg. Paracetamol is an analgesic that reduces pain and fever. Ibuprofen belongs to the group of medicines NSAIDs, which also reduce pain and fever. The combination of paracetamol 500 mg and ibuprofen 200 mg (NURULIN DUO tablets) is used for the symptomatic relief of mild to moderately severe pain due to migraine, headaches, backaches, menstrual pain, dental pain, rheumatic and muscle pain, pain in arthritis and symptoms of flu and colds. If you have any questions about this medicine, please ask your pharmacist or doctor for further information. If after three days the situation does not improve or the symptoms get worse, please immediately contact a doctor. 2. What you should know before taking NURULIN DUO Do not take NURULIN DUO

• if you are allergic to the active substance(s) or any of the other ingredients (excipients) of this medicine (listed in section 6);
• if you have (or have had before) bleeding from the rectum (anus), if you have black sticky bowel movements (stools) or bloody diarrhea;
• if you have a peptic ulcer (e.g. gastric or duodenal ulcer), a recent history of such one or have had a peptic ulcer before;
• with other medicines containing paracetamol or ibuprofen;
• if you regularly drink large amounts of alcohol;
• if you have severe heart failure, hepatic failure or renal failure;
• if you have cerebrovascular or other active bleeding;
• if you have problems with blood clotting;
• if you have asthma, urticaria, or allergic-type reactions after taking aspirin/acetylsalicylic acid or other NSAIDs;
• during the last three months of pregnancy;
• you are under 18 years of age. Warning and precautions

Talk to your doctor or pharmacist before taking NURULIN DUO. Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially when they are used in high doses. Do not exceed the recommended dose or duration of treatment. You should discuss the treatment with your doctor or pharmacist before taking NURULIN DUO, if:

• you have heart problems, including heart failure and angina pectoris (chest pain) or have suffered a heart attack, have undergone heart bypass surgery, peripheral artery disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any kind of stroke (including micro-stroke or transient ischemic attack);
• you have high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker;
• you have liver disease, hepatitis, kidney disease or difficulty urinating;
• you are an alcoholic or drug addict;
• you are allergic to other medicines containing aspirin/acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, or other substances listed at the end of this leaflet;
• you are pregnant or planning to become pregnant;

• breastfeeding or planning to breastfeed;
• you have recently had an infection;
• you are planning to be operated;
• you have or have had other medical conditions, including:
• heartburn, indigestion, stomach ulcers or other stomach problems;
• vomiting blood or bleeding from the anus;
• severe skin reactions such as Stevens-Johnson syndrome;
• asthma;
• vision problems;.
• susceptibility to bleeding or other blood problems; intestinal problems, such as ulcerative colitis or Crohn’s disease; swelling of ankles or feet; diarrhea;
• heritable genetic or acquired disease of certain enzymes, as manifested by neurological complications or skin problems, or sometimes by both, for example, porphyria;
• smallpox;
• autoimmune diseases such as lupus erythematosus.

Do not drink alcoholic beverages when taking this medicine. Combining alcohol with NURULIN DUO can lead to liver damage. The product belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which can affect fertility in women. This effect is reversible when stopping the drug. Taking NURULIN DUO can affect the results of urine tests for 5-Hydroxyindoleacetic acid (5HIAA), showing false positive results. To avoid false results, do not take NURULIN DUO or other products containing paracetamol, a few hours before or during sample collection for urine. Children and adolescents This product is not recommended for children under 18 years of age. Other medicines and NURULIN DUO Consult your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. NURULIN DUO can affect or be affected by some other medicines. For example:

• drugs with anti-clotting action (i.e. thin the blood/prevent clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines to treat epilepsy or seizures such as phenytoin
• chloramphenicol, antibiotic used for the treatment of ear and eye infections
• probenecid, a drug used to treat gout
• zidovudine, a drug used to treat HIV (the virus that causes AIDS)
• drugs used for treatment of tuberculosis, such as isoniazid
• aspirin/acetylsalicylic acid, salicylates and other nonsteroidal anti-inflammatory drugs
• drugs that reduce high blood pressure (ACE-inhibitors such as captopril, beta blockers such as drugs containing atenolol, angiotensin II receptor antagonists, such as losartan)
• drugs for other heart diseases such as digoxin
• diuretics, also called water tablets
• lithium, a medicine used for treating certain types of depression
• methotrexate, a medicine used for the treatment of arthritis and certain types of cancer
• corticosteroids, such as prednisone, cortisone
• metoclopramide, propantheline
• tacrolimus or cyclosporine, immunosuppressive drugs used after organ transplants
• sulfonylureas, drugs used to treat diabetes
• some antibiotics (such as quinolone antibiotics)

These medicines may be affected by NURULIN DUO or could affect the action of NURULIN DUO. You may need different amounts of your medicines or you may need to use different drugs. Some other medicines can also affect or be affected by the treatment with NURULIN DUO. Therefore, always before using NURULIN DUO with other drugs you should consult your doctor or pharmacist. Your doctor or pharmacist has more information about these or other drugs that must be careful or avoid while taking this medicine. Pregnancy, breastfeeding and fertility If you are pregnant or breastfeeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. Do not take this medicine during the last 3 months of your pregnancy. Pay special attention, if you are in the first 6 months of pregnancy. This product may impair female fertility and is not recommended in women trying to conceive. Driving and using machines Be careful driving or operate machinery until you know how NURULIN DUO affects you. 3. How to take NURULIN DUO Always take this medicine exactly as described in this leaflet or as you have been told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. The recommended dose in adults over 18 years of age is 1 tablet with food and water three times a day. Observe intervals of at least 6 hours to your next dose. Always use the minimum effective dose for the shortest possible time. If symptoms become worse or persist for longer than 3 days, consult your doctor immediately. Do not take more than the maximum allowable daily dose – 6 tablets, which is equivalent to 3000 mg of paracetamol and 1200 mg of ibuprofen per day. Use in children and adolescents NURULIN DUO tablets should not be taken by children under 18 years of age. If you take more than the necessary dose of NURULIN DUO tablets If you or someone else accidentally or intentionally takes more tablets at once, or if you suspect that a child has taken a tablet, you should contact your doctor or nearest hospital immediately, because of the possibility of serious liver damage. If you forget to take NURULIN DUO tablets Do not take a double dose to make up for a missed dose. If you forget to take the tablet, take it as soon as you remember unless it is almost time for your next dose. If you stop taking NURULIN DUO tablets If you have any further questions related to the use of this medicine, ask your doctor or pharmacist. 4. Possible adverse reactions Like all medicines, this medicine can cause adverse reactions, although not everybody gets them. If you get any adverse reactions, please tell your doctor or pharmacist. The adverse reactions may occur with certain frequencies, which are defined as follows: The following rare serious adverse reactions have been reported: If any of these serious adverse reactions occur, stop taking NURULIN DUO and tell your doctor immediately or go to the Emergency Room at the nearest hospital:

• vomiting blood or material that looks like coffee grounds;
• bleeding of the anus, sticky black stools or bloody diarrhea;
• swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing;
• asthma, wheezing, shortness of breath;
• sudden or severe itching, skin rash, urticaria;
• blistering and bleeding in the lips, eyes, mouth, nose and genital area (Stevens-Johnson syndrome)
• fever, malaise, nausea, stomach pain, headache and stiff neck.

More common adverse reactions include the following:

• nausea or vomiting
• loss of appetite
• heartburns or pain in the upper part of the stomach
• cramping, bloating, constipation or diarrhea
• skin rashes
• headache
• dizziness
• insomnia
• moodiness, such as depression, confusion, nervousness

The following adverse reactions have also been reported rarely:

• severe pain or painfulness in the stomach
• eye problems such as blurred vision, red eyes, itching
• signs of frequent or disturbing infections such as fever, severe chills, sore throat or mouth ulcers
• bleeding or bruising more easily than normal, red or purple spots under the skin
• signs of anemia, such as fatigue, headaches, shortness of breath and pallor
• yellowing of the skin and/or eyes, so called jaundice
• unusual weight gain, swelling of the ankles or legs
• formication in hands and feet
• symptoms of sunburn (such as redness, itching, swelling, blisters), which may occur more rapidly than normal
• strong or prolonged headache
• fast or irregular heartbeats, also called palpitation.

The above list includes serious adverse reactions that may require medical attention. The serious adverse reactions are rare at low doses of this medicine and when it is used for a short period of time Reporting of suspected adverse reactions Reporting of suspected adverse reactions after marketing authorization of the medicinal product is important. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Medical professionals are required to report any suspected adverse reaction through: Bulgarian Drug Agency 1303 Sofia, 8 Damyan Gruev Str. Tel: +359-28903417 Website: www.bda.bg 5. How to store NURULIN DUO Store in the original package at a temperature below 25°C in a dry place and protected from light. Keep out of the reach and sight of children. Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month. Do not dispose of medicines in the sewerage or household waste bin. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. 6. Contents of the package and further information What NURULIN DUO contains:

• The active/medicinal substances in each tablet are paracetamol 500 mg and ibuprofen 200 mg:
• The other ingredients (excipients) include: colloidal silicon dioxide, croscarmellose sodium, pregelatinized starch, stearic acid, povidone K30, corn starch, microcrystalline cellulose.

What NURULIN DUO looks like and contents of the package NURULIN DUO are white oblong tablets with a length of 20.0 mm and a width of 8.2 mm. The product is available in packages of 10/20 tablets or 12/24 tablets packaged in a blister of PVC/AL foil, one or two blisters in a cardboard box with a leaflet. Marketing Authorisation Holder and Manufacturer Ramcopharm Ltd. 5a Plachkovitsa Str. 1164 Sofia, Bulgaria TEL.: +359 2 868 8052 Date of the latest revision of the leaflet: July 2016 This leaflet describes only the most important things you need to know about the combination of paracetamol and ibuprofen. If you have further questions, ask your doctor or pharmacist.