500 mg / 150 mg film-coated tablets 
paracetamol / ibuprofen

1. What Dolerin is and what it is used for

Dolerin contains both paracetamol and ibuprofen .

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs ). It is analgesic, inhibits inflammation (swelling, redness, or tenderness), and is antipyretic. Paracetamol is analgesic and antipyretic.

Dolerin is used for temporary relief of acute pain such as headache (not a migraine ), back pain, toothache, muscle pain, and sore throat. Dolerin is also used for fever.

Paracetamol and ibuprofen contained in Dolerin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Dolerin

Do not use Dolerin

  • if you are allergic to paracetamol and/or ibuprofen or any of the other ingredients of this medicine (listed in section 6)
  • if you have or have had gastrointestinal bleeding in the form of, among other things, bleeding from the rectum, black sticky stools, or bloody diarrhea
  • if you have or have had stomach ulcers or ulcers in the duodenum (peptic ulcer)
  • if you have had asthma, hives, or allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs ( NSAIDs )
  • if you frequently consume large amounts of alcohol
  • if you have severe kidney or liver failure
  • if you have severe heart failure
  • if you have a cerebral hemorrhage or another active bleeding
  • if you have problems with bleeding and an increased tendency to bleed
  • during the last three months of pregnancy

Warnings and cautions

Anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when using high doses. Do not exceed the recommended dose or treatment time.

You should discuss your treatment with a doctor or pharmacist before taking Dolerin if you:

  • have heart problems including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked blood vessels), or some form of stroke(including “mini-stroke”) or transient ischemic attack ( TIA )).
  • have high blood pressure, diabetes, high cholesterol, have a history of heart disease or stroke in the family, or if you are a smoker.

Talk to your doctor or pharmacist before using Dolerin

  • if you have liver or kidney disease or if you are dehydrated
  • if you are taking other painkillers, including paracetamol and non-steroidal anti-inflammatory drugs ( NSAIDs ), and acetylsalicylic acid, as these may increase the risk of serious side effects
  • if you are older (over 65 years), as the risk of side effects is greater
  • if you have chickenpox
  • if you have porphyria (a hereditary disease that affects the red blood cell pigment hemoglobin )
  • if you have an infection – see the heading “Infections” below
  • if you have or have had any other medical conditions, such as:
    • heartburn, indigestion, stomach ulcers, or other stomach problems
    • severe skin reactions such as Steven-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
    • asthma
    • increased tendency to bleed or other problems with the blood
    • intestinal diseases such as ulcerative colitis or Crohn’s disease
    • swelling of the ankles or feet
    • autoimmune disease, such as systemic lupus erythematosus ( SLE )

Skin reactions

Serious skin reactions have been reported with Dolerin treatment. You should immediately stop taking Dolerin and seek medical attention if you develop any skin rash, mucous membrane ulcers, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Prolonged or frequent use of painkillers can cause headaches that should not be treated by increasing the dose. If this happens, stop treatment and consult a doctor.

Never take Dolerin more than what is stated in the dosing instructions. Higher doses than those recommended do not provide better pain relief but instead entail a risk of very serious liver damage. The symptoms of liver damage usually come only after a few days. Therefore, you must contact a doctor as soon as possible if you have taken too large a dose.

Do not use Dolerin without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Dolerin with alcohol. The intoxicating effect of alcohol does not increase with the addition of Dolerin.

Tell your doctor that you are taking Dolerin if you are asked to give a urine sample, as this medicine may cause incorrect results in some samples.

Infection is

Dolerin can hide signs of infection such as fever and pain. Therefore, Dolerin may delay the appropriate treatment of infection and increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox. If you take this medicine while you have an infection and the symptoms of infection persist or worsen, you should contact a doctor immediately.

Children and young people

Dolerin should not be used in the treatment of children and adolescents under 18 years of age.

Other drugs and Dolerin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Dolerin may affect or be affected by certain other medicines. For example:

  • anticoagulants (ie blood thinners, eg acetylsalicylic acid, warfarin, ticlopidine)
  • medicines used to treat epilepsy or seizures (such as phenytoin, phenobarbital, carbamazepine)
  • chloramphenicol, an antibiotic used to treat ear and eye infections
  • probenecid, a drug used to treat gout
  • zidovudine, a medicine used to treat HIV (the virus that causes AIDS)
  • tuberculosis drugs such as isoniazid and rifampicin
  • acetysalicylic acid, salicylates and other NSAIDs
  • medicines that lower high blood pressure ( ACE inhibitors eg captopril, beta-blockers eg atenolol, angiotensin -II receptor antagonists eg losartan)
  • medicines used to treat heart disease (eg digoxin or beta-blockers)
  • mifepristone, a medicine used in medical abortion
  • diuretics , also called diuretics
  • medicines used to treat mania or depression (eg lithium or SSRIs)
  • methotrexate, which is used to treat joint inflammation ( arthritis ) and certain types of cancer
  • corticosteroids, such as prednisone and cortisone
  • antiemetic drugs (eg metoclopramide and domperidone)
  • medicines for high cholesterol (eg cholestyramine)
  • tacrolimus or ciclosporin, immunosuppressive drugs used after organ transplants
  • sulphonylureas (medicines used to treat diabetes)
  • a type of antibiotic called aminoglycosides
  • antifungal drugs such as voriconazole or fluconazole

Consult your doctor or pharmacist for more information on how to use these medicines.

Some other medicines may also affect or be affected by treatment with Dolerin. You should therefore always consult your doctor or pharmacist before using Dolerin with other medicines.

Do not use different types of painkillers at the same time unless your doctor has explicitly prescribed them (see also “Warnings and precautions”).

Dolerin with alcohol

Do not use Dolerin without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Dolerin with alcohol. The intoxicating effect of alcohol does not increase with the addition of Dolerin.

Pregnancy, breastfeeding, and fertility

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.

Pregnant women should not use Dolerin during the last months of pregnancy.

Taking Dolerin should be avoided by women who are planning to become pregnant or are pregnant. Ingestion during pregnancy should only be taken if necessary and as prescribed by a doctor.

Dolerin can be used during breast-feeding for short-term treatment and at recommended doses.

Dolerin can make it harder to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems getting pregnant.

Driving and using machines

Dolerin can cause dizziness, drowsiness, fatigue, and visual disturbances in some people. Be careful when driving or using machines until you know how Dolerin affects you. This should be taken into account when sharper attention is required, e.g. while driving. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dolerin contains lactose

If your doctor has told you that you are hypersensitive to certain sugars, you should consult your doctor before using this medicine.

3. How to use Dolerin

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The dolerin should only be used for short-term use.

The lowest effective dose should be used for the shortest possible time to relieve symptoms. Contact a doctor immediately if you have an infection and the symptoms (such as fever and pain) persist or worsen (see section 2).

Higher doses than those recommended can lead to serious risks.

Adults: The recommended dose is 1 to 2 tablets every six hours if needed.

Do not take more than 8 tablets in a 24 hour period.

The dolerin should be taken with a full glass of water with or without a meal.

The breaker is not for dividing the tablet into equal doses but only for easier swallowing.

Elderly: There is no evidence that the dose needs to be changed in the elderly, but if you are older you may be more sensitive to serious side effects, especially bleeding and perforation in the gastrointestinal tract.

Liver or kidney problems: If you have liver or kidney problems, your dose may need to be reduced or the time between doses increased. Consult a doctor.

If you use more Dolerin than you should

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Do this even if you do not show signs of discomfort or poisoning.

Symptoms may include nausea, vomiting (with blood), headache, ringing in the ears, confusion, and jerky involuntary eye movements. At high doses, drowsiness, chest pain, palpitations, unconsciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills, and difficulty breathing have been reported.


If you take too many Dolerin tablets, it can lead to severe liver damage that appears after a few days and can be fatal. You may need urgent medical attention.

If you forget to use Dolerin

If it is time for your next dose, skip the missed dose and take the next dose as usual. Otherwise, take a dose as soon as you remember and then continue to take the tablets as usual. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist. There should always be at least 6 hours between doses.

If you have any further questions on the use of this product, 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, talk to your doctor or pharmacist.

If you experience any of the following serious side effects, stop using Dolerin and contact a doctor immediately or go to the nearest emergency department.

Uncommon (may affect up to 1 in 100 people):

  • bloody vomiting or vomiting that looks like coffee grounds. Bleeding from the rectum, black sticky stools, or bloody diarrhea. This may be a sign of bleeding from the intestines.
  • swelling of the face, lips, or tongue which may cause difficulty in swallowing or breathing. Sudden and severe itching ( pruritus ), skin rash, hives ( urticaria ). This may be a sign of a severe allergic reaction.

Very rare (may affect up to 1 in 10,000 people):

  • asthma, wheezing, shortness of breath

In very rare cases, severe skin reactions occur.

No known frequency (cannot be calculated from the available data):

  • fever, general malaise, nausea, abdominal pain, headache, and stiff neck. This may be a sign of meningitis.
  • a severe skin reaction called DRESS syndrome may occur. Symptoms of DRESS include skin rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell ).
  • widespread red, scaly rash with bumps under the skin and blisters mainly in the folds of the skin, on the torso and arms together with fever at the beginning of treatment ( acute generalized exanthematous pustulosis ). Stop using Dolerin immediately if you develop these symptoms and seek medical attention immediately. See also section 2.

Other side effects:

Common (may affect less than 1 user in 10):

  • changes in liver or kidney function (determined by a blood test)
  • ringing in the ears ( tinnitus )
  • nausea or vomiting
  • heartburn or abdominal pain
  • cramps, bloating, bloating, stomach upset, constipation, or diarrhea
  • skin rash, itching, swelling of the lips, eyes, hand,s or feet
  • dizziness
  • fatigue, agitation, irritability, nervousness
  • headache, dizziness
  • fluid retention and swelling, which usually improves when treatment is stopped

Uncommon (may affect up to 1 in 100 people):

  • gastric ulcer or ulcer in the duodenum and ( peptic ulcers ), bleeding in the gastrointestinal tract, abdominal pain ( gastritis )
  • inflammation of the lips and mouth ( stomatitis )
  • worsening of existing ulcerative colitis or Crohn’s disease
  • inflammation of the pancreas ( pancreatitis )
  • difficulty urinating
  • changes in the number of red or white blood cells or other changes in the composition or acidity of the blood (determined by blood tests)
  • enlarged mammary glands (in men)
  • abnormally low blood sugar (hypoglycemia)
  • mood swings, e.g. depression, confusion, emotional instability, insomnia, drowsiness
  • signs of anemia ( anemia ), such as fatigue, headaches, shortness of breath, and pallor
  • frequent or disturbing infection such as fever, severe chills, sore throat, or cold sores
  • increased tendency to bleeding or bruising, reddish or purple spots under the skin
  • allergic reactions
  • visual disturbances such as blurred vision, changes in color vision, or blind spots
  • fast or slow pulse
  • skin reactions and photosensitivity
  • kidney problems that cause increased or decreased urine output, swelling in the legs, blood in the urine, or pain in the side of the abdomen
  • hair loss

Rare (may affect up to 1 in 1,000 people):

  • tingling in hands and feet
  • abnormal dreams, hallucinations

Very rare (may affect up to 1 in 10,000 people):

  • movement problems such as inability to sit still or to start and control a movement
  • anxiety and restlessness
  • uncontrolled tremors or convulsions (seizures)
  • tarmvred
  • infection that causes tissue death, unusual weight gain, swelling in the ankles or bones
  • symptoms of sun sensitivity (such as redness, itching, swelling, blisters) which means that you burn faster in the sun.
  • excessive sweating
  • fast or irregular pulse also called palpitations
  • heart failure, heart attack, high or low blood pressure
  • kidney failure
  • liver problems and yellow-toned skin and/or eyes also called jaundice

5. How to store the Dolerin

Keep out of sight and reach of children and young people.

Do not store above 30 ° C.

Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are paracetamol and ibuprofen . Each film-coated tablet contains 500 mg paracetamol and 150 mg ibuprofen.
  • The other ingredients are corn starch, pregelatinized corn starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc. Tablet cover: HPMC 2910 / hypromellose 15cP (E464), lactose monohydrate , titanium dioxide (E171), macrogol / PEG-4000, sodium citrate dihydrate (E331).

What the medicine looks like and the contents of the pack

Dolerin film-coated tablets are white capsule-shaped, film-coated tablets, length 19 mm, with a scoreline on one side and smooth on the other side.

They come in blister packs containing 8, 10, 12, 16, 20, 24, 30, 32, 50 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Manufacturer

Alterno AD doo, PE

Brnčičeva Ulica 29

Ljubljana-Črnuče, 1231

Slovenia

Aziende Chimiche Riunite

Angelini Francesco ACRAF SPA

Via Vecchia del Pinocchio

22 60131 Ancona

Italy

Muhammad Nadeem

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