NURULIN DUO 500mg/200mg x 20 tabl
LEAFLET: INFORMATION FOR THE USER
NURULIN DUO 500 mg/200 mg tablets
NURULIN DUO 500 mg / 200 mg tablets
paracetamol ( paracetamol )/ibuprofen ( ibuprofen )
Read all of this 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 your pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- Do not take this product for more than 3 days or if symptoms worsen, unless directed by a doctor.
What this leaflet contains:
- What is NURULIN DUO and what is it used for.
- What you should know before taking NURULIN DUO.
- How to take NURULIN DUO
- Possible side effects.
- How to store NURULIN DUO
- Package contents and additional information.
- What is NURULIN DUO and what is it 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 nonsteroidal anti-inflammatory drugs, 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 moderate pain resulting from migraine, headache, back pain, menstrual pain, toothache, rheumatic and muscle pain, arthritis pain and the symptoms of flu and colds.
If you have any questions about this medicine, please ask your pharmacist or doctor for more information.
If after 3 days the condition does not improve or the symptoms worsen, please seek medical attention immediately.
- What you need to know before you take NURULIN DUO
Do not take NURULIN DUO
- if you are allergic to the active substance(s) or to any of the other ingredients (excipients) of this medicine (listed in point 6);
- if you have (or have had) bleeding from the rectum (anus), if you have black stools or bloody diarrhoea;
- if you have a peptic ulcer (e.g. gastric or duodenal ulcer), a recent history of one, or have had a peptic ulcer before;
- with other medicines containing paracetamol or ibuprofen;
- if you regularly consume large amounts of alcohol;
- if you have severe heart failure, liver failure or kidney failure;
- if you have cerebrovascular or other active bleeding;
- if you have problems with blood clotting;
- if you have asthma, hives 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking NURULIN DUO.
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dosage or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking NURULIN DUO if:
- have heart problems, including heart failure and angina (chest pain), or have had a heart attack, bypass surgery, peripheral artery disease (impaired circulation in the legs or feet due to narrowed or blocked arteries) or any type of stroke ( including microstroke or transient ischemic attack);
- you have high blood pressure, diabetes, high cholesterol, a 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 non-steroidal anti-inflammatory drugs, or to other substances listed at the end of this leaflet;
- you are pregnant or planning to become pregnant;
- are breastfeeding or planning to breastfeed;
- you have recently had an infection;
- you plan to have surgery;
- you have or have had other medical conditions, including:
- heartburn, indigestion, stomach ulcer or other stomach problems;
- vomiting blood or bleeding from the anus;
- severe skin reactions, such as Stevens Johnson syndrome;
- bleeding tendency or other blood problems; intestinal problems, such as ulcerative colitis or Crohn's disease; swelling of the ankles or feet; diarrhea;
- an inherited genetic or acquired disease of certain enzymes that presents with neurological complications or skin problems, or sometimes both, e.g. porphyria;
- smallpox;
- autoimmune diseases such as lupus erythematosus.
Do not drink alcoholic beverages while taking this medicine. Combining alcohol with NURULIN DUO can cause liver damage.
The product belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs), which can affect women's fertility. This effect is reversible when the drug is stopped.
Taking NURULIN DUO may affect the results of urine tests for 5-hydroxyindoleacetyl acid (5HIAA), showing false positive results. To avoid false results, do not take NURULIN DUO or other products containing paracetamol for several hours before or during urine sample collection.
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, have recently taken or might take any other medicines.
NURULIN DUO can affect or be affected by some other medicines.
For example:
- Anticoagulant medicines (ie blood thinners / prevent clotting eg aspirin/acetylsalicylic acid, warfarin, ticlopidine);
- medicines to treat epilepsy or seizures such as phenytoin;
- chloramphenicol, an antibiotic used to treat ear and eye infections;
- probenecid, a medicine used to treat gout;
- zidovudine, a medicine used to treat HIV (the virus that causes AIDS);
- drugs used to treat tuberculosis, such as isoniazid;
- aspirin/acetylsalicylic acid, salicylates, or other nonsteroidal anti-inflammatory drugs;
- medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan);
- medicines for other heart conditions such as digoxin;
- diuretics, also called water pills;
- lithium, a medicine used to treat some types of depression;
- methotrexate, a medicine used to treat arthritis and some types of cancer;
- corticosteroids, such as prednisone, cortisone;
- metoclopramide, propantheline;
- tacrolimus or cyclosporine, immunosuppressive drugs used after organ transplantation;
- sulphonylureas, medicines used to treat diabetes;
- certain antibiotics (such as quinolone antibiotics).
These medicines may be affected by NURULIN DUO or may affect the action of NURULIN DUO. You may need different amounts of your medicines or different medicines may need to be used.
Some other medicines can also affect or be affected by treatment with NURULIN DUO. Therefore, always before using NURULIN DUO with other medicines, you should consult your doctor or pharmacist.
Your doctor or pharmacist has more information about these or other medicines that you should be careful with or avoid while taking this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using 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 for women trying to conceive.
Driving and using machines
Be careful driving or operating 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 your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults over 18 years old is 1 tablet with water and food 3 times a day. Keep an interval of at least 6 hours before the next dose. Always use the minimum effective dose for the shortest possible time. If symptoms worsen or do not disappear within 3 days consult your doctor immediately. Do not take more than the maximum permissible 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 have taken more than the required dose of NURULIN DUO tablets
If you or someone else accidentally or deliberately takes more tablets at one time, or if you suspect that a child has taken a tablet, you should contact your doctor or the nearest hospital immediately because of the possibility of serious liver damage.
If you have forgotten to take NURULIN DUO tablets
Do not take a double dose to make up for a missed dose.
If you have forgotten to take the tablet , take it as soon as you remember, unless it is almost time for the next dose.
If you have stopped taking NURULIN DUO tablets
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, tell your doctor or pharmacist. Side effects may occur with certain frequencies, which are defined as follows: The following rare serious side effects have been reported:
If you experience any of these serious side effects, stop taking NURULIN DUO and tell your doctor immediately or go to the Emergency Department at the nearest hospital:
- vomiting blood or material that looks like coffee grounds;
- bleeding from the anus, black sticky stools, or bloody diarrhea;
- swelling of the face, lips, or tongue, which may cause difficulty swallowing or breathing;
- asthma, wheezing, shortness of breath;
- sudden or severe itching, skin rash, hives;
- blistering and bleeding in the lips, eyes, mouth, nose and genitals (Stevens Johnson Syndrome)
- fever, general malaise, nausea, stomach pain, headache and stiff neck.
Other side effects
Common: may affect up to 1 in 10 people
- nausea or vomiting;
- loss of appetite;
- heartburn or stomach pain;
- cramping, gas, constipation, or diarrhea;
- skin rashes;
- change in mood eg depression, confusion, nervousness.
Rare: may affect up to 1 in 1,000 people
- severe pain or soreness in the stomach;
- eye problems such as blurred vision, red eyes, itching;
- signs of frequent or worrying infections, such as fever, severe chills, sore throat or mouth ulcers;
- bleeding or bruising more easily than normal reddish or purple spots under the skin;
- signs of anemia, such as fatigue, headache, shortness of breath, and paleness;
- yellowing of the skin and/or eyes, the so-called jaundice;
- unusual weight gain, swelling of the ankles or feet;
- numbness of hands and feet;
- sunburn symptoms (such as redness, itching, swelling, blisters) that may occur more quickly than normal;
- severe or prolonged headache;
- fast or irregular heartbeat, called palpitations.
The above list includes serious side effects that may require medical attention. Serious side effects are rare with low doses of this drug and when used for a short period of time
Reporting adverse drug reactions
Post-marketing reporting of suspected adverse reactions is important. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any suspected adverse reaction by:
Medicines Executive Agency
8 Damyan Gruev St., Sofia 1303
phone: +359-28903417
website: www.bda.bg
5. How to store NURULIN DUO
To be stored in the original packaging, at a temperature below 25°C in a dry place protected from light.
To be stored in a place inaccessible to children.
Do not use this medicine after the expiry date which is stated on the label. The expiration date corresponds to the last day of the specified month. Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
- Package contents and additional information
What NURULIN DUO contains
- The active substances in each tablet are paracetamol 500 mg and ibuprofen 200 mg:
- The other ingredients (excipients) are: anhydrous, colloidal silicon dioxide, croscarmellose sodium, pregelatinized starch, stearic acid, povidone K30, corn starch, microcrystalline cellulose.
What NURULIN DUO looks like and what the package contains
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 packs of 10, 12, 20 or 24 tablets packed in a PVC/Al foil blister. One or two blisters in a single cardboard box with a leaflet.
Not all types of packaging can be put on sale.
Marketing Authorization Holder and Manufacturer
Ramkofarm EOOD
5a Plachkovitsa St
Sofia 1164
Bulgaria
tel: +359 2 868 8052
Date of last revision of leaflet: April 2022
This leaflet describes only the most important things you need to know about the combination of paracetamol and ibuprofen. If you have any further questions, ask your doctor or pharmacist.
