DOLOSTOP PLUS 500 MG/150 MG FILM-COATED TABLETS

Introduction

Patient Information Leaflet:Information for the Patient

Dolostop Plus 500 mg/150mg film-coated tablets

paracetamol/ibuprofen

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• Do nottake this medication for more than 3days.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the Leaflet

1. What Dolostop Plus is and what it is used for
2. What you need to know before taking Dolostop Plus
3. How to take Dolostop Plus
4. Possible side effects
5. Storage of Dolostop Plus
6. Packaging contents and additional information

1. What Dolostop Plus is and what it is used for

This medication contains paracetamol and ibuprofen.

Paracetamol prevents pain signals from reaching the brain.

Ibuprofen belongs to a group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). It relieves pain and reduces inflammation (swelling, redness, or pain).

Dolostop Plus is used for the symptomatic treatment of occasional mild to moderate pain.

If you have any doubts, consult your doctor or pharmacist.

You should consult a doctor if it worsens or does not improve after 3 days.

2. What you need to know before taking Dolostop Plus

Do not take Dolostop Plus:

• if you are allergic to the active substances or to any of the other components of this medication (listed in section 6).
• if you have a history of gastrointestinal bleeding or perforation associated with previous treatment with NSAIDs.
• if you have active peptic ulcer or recurrent peptic ulcer (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of ulceration or hemorrhage diagnosed).
• if you regularly consume large amounts of alcohol.
• if you have severe heart failure, liver failure, or kidney failure.
• if you have a history of stroke or other active bleeding.
• if you have blood clotting disorders.
• if you have asthma, urticaria, or allergic reactions after taking acetylsalicylic acid or other NSAIDs.
• during the last three months of pregnancy.
• if you are under 18 years old.

Warnings and Precautions

Talk to your doctor or pharmacist before taking this medication.

Anti-inflammatory and analgesic medications, such as ibuprofen, may be associated with a small increased risk of suffering a heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Dolostop Plus immediately and contact your doctor or medical emergency service immediately if you notice any of these signs.

You should discuss treatment with your doctor or pharmacist before taking this medication if:

• you have heart problems, such as heart failure or angina (chest pain), if you have had a heart attack, surgical revascularization, peripheral arterial disease (poor circulation in legs or feet due to narrowing or blockage of arteries) or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Inform your doctor or pharmacist if:

• you have liver disease, hepatitis, kidney disease, or difficulty urinating.
• you use drugs.
• you are pregnant or trying to become pregnant.
• you are breastfeeding or plan to breastfeed.
• you currently have an infection; see "Infections" heading below.
• you are scheduled to undergo surgery.
• you have or have had other medical conditions such as:

• gastric acidity, indigestion, stomach ulcer, or any other stomach problem.
• bloody vomiting or rectal bleeding.
• severe skin reactions such as exfoliative dermatitis, toxic epidermal necrolysis, and Stevens-Johnson syndrome.
• asthma.
• vision problems.
• bleeding tendency or other blood disorders.
• intestinal problems such as ulcerative colitis or Crohn's disease.
• swelling of the ankles or feet.
• diarrhea.
• inherited or acquired genetic disorder of certain enzymes that manifests with neurological or skin complications or both, i.e., porphyria.
• smallpox.
• autoimmune disease such as lupus erythematosus or other connective tissue disorders.

Skin Reactions

Be particularly careful with Dolostop Plus:

Severe skin reactions have been reported, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), in association with ibuprofen treatment. Stop Dolostop Plus treatment and seek immediate medical attention if you notice any of these severe skin reaction symptoms described in section 4.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

To avoid the risk of overdose,

• check that other medications do not contain paracetamol,
• respect the maximum recommended doses (see section 3).

Do not consume alcoholic beverages during the use of this medication. The combination of alcohol with this medication can cause liver damage.

This product belongs to a group of medications (NSAIDs) that may affect fertility in women. This effect is reversible if the medication is stopped.

Prolonged use of analgesics may cause headache, which should not be treated by increasing the medication dose.

The use of this medication may interfere with the results of urine analysis for the detection of 5-hydroxyindoleacetic acid (5HIAA) and cause false-positive results. To avoid false results, do not take this medication or other products containing paracetamol for several hours before or during urine sample collection.

During treatment with Dolostop Plus, inform your doctor immediately if:

• If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and Adolescents

This medication is contraindicated in children and adolescents (under 18 years old).

Other Medications and Dolostop Plus

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

This medication may affect or be affected by other medications. For example:

• anticoagulant medications (i.e., blood-thinning agents, such as aspirin/acetylsalicylic acid, warfarin, and ticlopidine).
• medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• medications for treating epilepsy or convulsions.
• chloramphenicol, an antibiotic used to treat ear and eye infections.
• probenecid, a medication used to treat gout.
• zidovudine, a medication used to treat HIV (the virus that causes acquired immunodeficiency disease).
• medications used to treat tuberculosis, such as isoniazid.
• salicylates or other NSAIDs.
• diuretics.
• lithium, a medication used to treat certain types of depression.
• methotrexate, a medication used to treat arthritis and some types of cancer.
• corticosteroids, such as prednisone, cortisone.
• metoclopramide, propantheline, antidepressants with anticholinergic properties, and narcotic analgesics.
• cholestyramine, a medication used to reduce increased serum lipid levels.
• tacrolimus or cyclosporin, immunosuppressive drugs used after organ transplantation.
• sulfonylureas, a medication used to treat diabetes.
• certain antibiotics (such as quinolone antibiotics or cotrimoxazole).
• cardiac glycosides, medications to strengthen the heart.
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Some other medications may also affect or be affected by treatment with Dolostop Plus. Therefore, you should always consult your doctor or pharmacist before taking paracetamol/ibuprofen with other medications.

Your doctor and pharmacist will have more information about these and other medications that you should be careful with or avoid while taking this medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take this medication during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor.

If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, this medication may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

This medication may affect female fertility and is not recommended in women trying to conceive.

Driving and Using Machines

Be careful when driving or using machines until you know how this medication affects you.

Dolostop Plus contains lactose:

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Dolostop Plus

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. Do not take it for more than 3 days.

The effective lowest dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is:

Adults:The usual dose is one tablet (500 mg of paracetamol and 150 mg of ibuprofen) or two tablets (1000 mg of paracetamol and 300 mg of ibuprofen) every six hours, as needed, up to a maximum of six tablets in 24 hours.

Use the effective lowest dose for the minimum time necessary for symptom relief. You should consult a doctor if the symptoms persist or worsen or if the medication is needed for more than 3 days.

Do not take more than 6 tablets in a 24-hour period.

If your doctor prescribes a different dose, follow the instructions provided by the doctor.

Take this medication with a full glass of water. The score line is only for breaking the tablet and facilitating swallowing, but not for dividing it into equal doses.

Use in Children and Adolescents (Under 18 Years Old)

This medication is contraindicated in children and adolescents (under 18 years old).

If You Take More Dolostop Plus Than You Should

Consult a doctor immediately if you have taken an excessive amount of this medication, even if you feel well. The reason is that an excessive amount of paracetamol can cause severe liver damage late on. Do this even if you do not have signs of discomfort or intoxication. You may need urgent medical attention.

If you have taken more Dolostop Plus than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood clots), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

If You Forget to Take Dolostop Plus

If it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time. Otherwise, take it as soon as you remember and continue taking the tablets as usual.

Do not take a double dose to make up for missed doses.

If you are unsure whether to skip or not skip the dose, talk to your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If any of the side effects worsen or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Stop Dolostop Plus treatment and seek immediate medical attention if you notice any of the following symptoms:

- Reddish patches, not raised, target-like or circular on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

- Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).

- Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

If you experience any of these serious side effects, stop taking Dolostop Plus and inform your doctor or go to the emergency department of the nearest hospital:

Frequent:

• vomiting blood or coffee-ground-like material.
• rectal bleeding, black and tarry stools, or bloody diarrhea.
• swelling of the face, lips, or tongue, which may cause difficulty swallowing or breathing.

Very rare:

• asthma, wheezing, shortness of breath.
• sudden or severe itching, skin rash, hives.
• severe skin reaction with blisters and bleeding in lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome). Very rare cases of severe skin reactions have been reported.
• worsening of severe skin infections (you may notice rash, blistering, and skin color changes, fever, drowsiness, diarrhea, and discomfort) or worsening of other infections, including chickenpox or herpes zoster or severe infection with tissue destruction (necrosis) and skin peeling.
• fever, general discomfort, nausea, stomach pain, headache, and neck stiffness.

Other possible side effects are:

Frequent (may affect up to 1 in 10 people)

• nausea or vomiting.
• loss of appetite.
• gastric acidity or pain in the upper part of the stomach.
• cramps, gas, constipation or diarrhea, slight blood loss of digestive origin.
• skin rashes, skin itching.
• headache.
• dizziness.
• feeling of nervousness.
• ringing in the ears.
• unusual weight gain, swelling and fluid retention, swelling of the ankles or legs (edema).

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

• decrease in red blood cells, nosebleeds and more abundant menstruations.
• allergic reactions: skin rash, fatigue, joint pain (e.g., serum sickness, lupus erythematosus, Henoch-Schönlein vasculitis, angioedema).
• increase in breast tissue size in men; low blood sugar levels.
• insomnia.
• mood change, such as depression, confusion, nervousness.
• eye problems such as blurred vision (reversible), red and irritated eyes, itching.
• increased mucus thickness.
• severe pain or discomfort when touching the stomach; peptic/digestive ulcer.
• inflammation of the intestine and worsening of colon inflammation (colitis) and digestive tract (Crohn's disease), as well as complications of large intestine diverticula (perforation or fistula).
• inability to empty the bladder completely (urinary retention).
• abnormal analytical results (blood test results and liver and kidney enzyme tests).

Rare (may affect up to 1 in 1000 people):

• tingling of hands and feet.
• abnormal dreams, vision of things (hallucinations).
• kidney tissue damage (especially with prolonged use).
• high blood levels of uric acid (hyperuricemia).

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

• low potassium levels: weakness, fatigue, muscle cramps (hypokalemia).
• signs of anemia, such as fatigue, headaches, shortness of breath and pale appearance.
• bleeding or bruising more easily than normal, reddish or purplish spots under the skin.
• severe or persistent headache.
• feeling that everything is spinning (vertigo).
• rapid or irregular heartbeat; also called palpitations.
• increased blood pressure and possible heart problems.
• esophageal inflammation.
• yellowish color of the skin or eyes, also called jaundice.
• liver damage (especially with prolonged use).
• hair loss.
• increased sweating.
• signs of frequent or worrying infections such as fever, intense chills, sore throat or mouth ulcers.

Not known (cannot be estimated from the available data):

• a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation and elevated eosinophils (a type of white blood cell).
• generalized red scaly rash, with bumps under the skin and localized blisters mainly in skin folds, trunk and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medication if you experience these symptoms and seek medical attention immediately. See also section 2.
• The skin becomes sensitive to light.
• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

The above list includes serious side effects that may require medical attention. Serious side effects are rare with low doses of this medication and when used for a short period.

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Dolostop Plus

Keep this medication out of sight and reach of children.

This medication does not require any special storage temperature. Store in the original blister pack to protect it from light.

Do not use this medication after the expiration date shown on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the package is broken or shows signs of tampering.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Dolostop Plus 500 mg/150 mg film-coated tablets

The active ingredients are 500 mg of paracetamol and 150 mg of ibuprofen per tablet.

The other components of the tablet core are: corn starch, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc and in the tablet coating: Opadry white (containing hypromellose (E464), lactose monohydrate (see section 2), titanium dioxide (E171), macrogol/PEG 4000 and sodium citrate (E331)) and talc.

Appearance of Dolostop Plus and package contents

White film-coated tablets, capsule-shaped and 19 mm long, with a notch on one side and smooth on the other. The notch serves only to fractionate and facilitate swallowing but not to divide into equal doses.

Each package contains 8, 10, 16, 20, 24, 30 and 32 film-coated tablets packaged in blisters. Only some package sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Alterno Labs d.o.o,

Brnciceva ulica 29, Ljubljana-Crnuce, 1231,

Slovenia

This medication is authorized in the member states of the European Economic Area with the following names:

Portugal: Dolostop Duo 500 mg/150 mg film-coated tablets

Date of the last revision of this prospectus:December 2024

“Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”