250 mg granules in paracetamol sachet
What Pinex Strawberry is and what it is used for
Paracetamol belongs to the pharmacotherapeutic group of analgesics (painkillers) which at the same time have an antipyretic effect with a weak anti-inflammatory effect.
Pinex Strawberry is used for the treatment of temporary fever and pain conditions of a mild nature, such as fever in colds, headaches, toothaches, menstrual pains, and muscle and joint pain.
Paracetamol contained in Pinex Strawberry may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Pinex Strawberry
Do not take Pinex Strawberry
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
- if you have severe kidney problems
- if you have hepatitis
- if you are taking other medicines containing paracetamol as it may lead to severe liver damage
- if you have alcohol problems
Warnings and cautions
If you are taking other painkillers that contain paracetamol, do not use Pinex Strawberry without first talking to your doctor or pharmacist.
Never take more Pinex Strawberry than stated in the dosing instructions. Higher doses than those recommended do not provide better pain relief but instead carry the 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, even if you feel well. See also section 3 “if you have taken too much Pinex Strawberry”.
The risk of overdose is greater in patients with liver damage (without scar tissue) caused by alcohol use.
Do not use Pinex Strawberry without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Pinex Strawberry with alcohol. The intoxicating effect of alcohol does not increase with the addition of Pinex Strawberry.
Talk to your doctor or pharmacist before taking Pinex Strawberry.
- if you have kidney or liver disease
- if you are deficient in glucose -6-phosphate dehydrogenase (an enzyme )
- if you have anemia (abnormal red blood cell breakdown )
- if you have Gilbert’s syndrome (hereditary mild jaundice)
- if you are asthmatic and at the same time hypersensitive to acetylsalicylic acid
- if you know you have a condition that can lower your levels of glutathione (a substance that is important when secreting drugs) as this may increase the risk of side effects. Such conditions include malnutrition, kidney and liver disease, alcohol abuse, and blood poisoning.
Contact a doctor before using Pinex Strawberry if:
- the child is difficult to carry or has abdominal pain, stiff neck, or back pain.
- the child has severe problems with the ears, throat, or trachea.
If the child has a fever, contact a doctor if:
- the child has not drunk any fluid or lost a large amount of fluid due to persistent vomiting or diarrhea.
- the treatment did not have any effect on the pain or fever after the first day.
- new symptoms appear or stomach pain/stomach upset worsens or lasts a long time.
Long-term use or frequent use is not recommended. You should not take other medicines containing paracetamol at the same time. Taking several daily doses at one time can seriously damage the liver, in which case unconsciousness does not occur. However, medical care must be sought immediately. Prolonged use, except under medical supervision, can be harmful.
In case of high fever or signs of a secondary infection or, if symptoms persist for longer than 3 days, treatment should be re-evaluated.
Paracetamol should be used with caution in case of dehydration or chronic malnutrition. For adults and children weighing 50 kg or more, the total daily dose of paracetamol should be a maximum of 3 g. If your symptoms worsen or do not improve within 3 days or if you have a high fever, consult a doctor.
Headaches can occur due to long-term use, high dose, or incorrect use of painkillers. This headache should not be treated by raising the dose of one of the drugs.
Habitual use of painkillers, especially the combination of several different painkillers, can generally lead to persistent kidney damage with a risk of kidney failure ( analgesic nephropathy ).
Sudden discontinuation of long-term use, high dose, or improper use can lead to headache, fatigue, muscle aches, nervousness, and autonomic symptoms. These withdrawal symptoms are transient within a few days. Before passing, additional painkillers should be avoided and not resumed without medical advice.
You should not take Pinex Strawberry for long periods or in high doses without talking to your doctor or dentist.
Other medicines and Pinex Strawberry
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines that can affect the effect of Pinex Strawberry:
- alcohol
- probenecid (used to treat gout )
- drugs that can damage the liver e.g. phenobarbital (sleeping pills), phenytoin, carbamazepine, primidone (used to treat epilepsy ), isoniazid, rifampicin (used to treat tuberculosis ), St. John’s wort (herbal medicine for treating mild depression and relieving anxiety). Concomitant use of these drugs and paracetamol can cause liver damage.
- metoclopramide and domperidone (used to treat nausea). These may increase the uptake and onset of action of paracetamol.
- drugs that delay gastric emptying. These may delay the absorption and onset of action of paracetamol.
- cholestyramine (used to lower blood fats). Cholestyramine reduces the uptake and onset of action of paracetamol. Therefore, you should not take cholestyramine within one hour after taking paracetamol.
- blood-thinning drugs ( oral anticoagulants, especially warfarin ). Repeated intake of paracetamol for more than a week increases the tendency to bleed. Long-term treatment with paracetamol should therefore only take place under medical supervision. Occasional ingestion of paracetamol has no significant effect on the bleeding tendency.
Concomitant use of paracetamol and zidovudine (a medicine used to treat HIV infections ) increases the risk of decreased white blood cell count ( neutropenia ). This can affect the immune system and increase the risk of infection. Pinex Strawberry should therefore only be given concomitantly with zidovudine after medical advice.
Effects on laboratory tests
Paracetamol can affect uric acid tests and blood sugar tests
Pinex Strawberry with alcohol
Pinex Strawberry should not be taken with alcohol at the same time.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Pinex Strawberry can be used during pregnancy. However, you should use the lowest possible dose that relieves your pain and/or fever and use the medicine for the shortest possible time. Contact a doctor if the pain and/or fever do not decrease or if you need to take the medicine more often.
The recommended dose can be used during breastfeeding.
Driving and using machines
The use of Pinex Strawberry does not affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
Pinex Strawberry contains sorbitol (E420)
This medicine contains 600 mg of sorbitol in each sachet.
Sorbitol is a source of fructose. If you (or your child) do not tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents fructose from being broken down, consult a doctor before using this medicine.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Pinex Strawberry contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Pinex Strawberry contains sulfites
May in rare cases cause severe hypersensitivity reactions and convulsions in the trachea.
Pinex Strawberry contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per sachet, ie essentially ‘sodium-free’.
How to take Pinex Strawberry
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Note! Higher doses than those recommended carry a risk of very serious liver damage.
Dose one depends on the information in the table below and is determined by body weight and age. For children, a dose should be given based on the child’s weight (age indication is approximate).
The dosing interval depends on the symptoms and the maximum daily dose. Dose one should not be taken more often than every 4-6 hours.
250 mg sachet:
| Body weight (age) | Single dose [sachet] | Maximum daily dose [sachets] |
| 17 kg – 25 kg(4-8 years) | 1 sachet | 4 sachets (1000 mg) |
Do not use Pinex Strawberry for children under 12 years of age for more than 2 days unless your doctor prescribes otherwise.
Dosage method:
Pinex Strawberry is taken only by mouth.
Do not take Pinex Strawberry with a meal.
Granules (grains) should be taken directly into the mouth, on the tongue, and swallowed without water.
Special patient groups
Hepatic or renal impairment
In patients with hepatic or renal impairment, the dose should be reduced or the dosing interval extended. Consult a doctor or pharmacist.
Chronic alcoholism
If you have alcohol problems, do not use Pinex without a doctor’s prescription.
Elderly patients
Dose adjustment is not necessary for the elderly.
Children and young people
Pinex Strawberry 250 mg is not suitable for children under 4 years and children weighing less than 17 kg. There are other available dosage forms available for this patient group.
If you take more Pinex Strawberry than you should
Contact a doctor or emergency room in case of an overdose of Pinex Strawberry. Overdose has very serious consequences and can even lead to death.
Due to the risk of delayed liver damage, immediate treatment is necessary, even if you are feeling well. Symptoms may include nausea and vomiting and may not reflect the severity of the overdose or the risk of organ damage.
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.
If you forget to take Pinex Strawberry
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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Pinex Strawberry and contact a doctor immediately if you get any of the following symptoms ( angioedema ).
Rare side effects (may affect up to 1 in 1,000 people):
- angioedema: swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing
Other possible side effects are described below.
Rare (may affect up to 1 in 1,000 people):
- Disorders of the platelets (affects the blood’s ability to coagulate), disorders of stem cell function (disorders of the blood-forming cells in the bone marrow )
- Allergic reactions
- Depression, confusion, hallucinations
- Shaking, headache
- Visual disturbances
- Edema (abnormal accumulation of fluid under the skin)
- Stomach pain, bleeding in the stomach or intestines, diarrhea, nausea, vomiting
- Impaired liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver necrosis (liver cells die)
- Dizziness, malaise, fever, sedation, interaction with other drugs
- Overdose and poisoning
Very rare (may affect up to 1 in 10,000 people):
- Changes in the blood picture (decreased number of platelets, number of white blood cells, and neutrophils in the blood), hemolytic anemia (abnormal degradation of red blood cells )
- Low levels of glucose in the blood
- Liver poisoning (damage to the liver caused by chemical substances)
- Turbid urine and kidney disease
- Severe allergic reactions requiring discontinuation of treatment
Very rare cases of severe skin reactions have been reported.
Has been reported (occurs in an unknown number of users):
Erythema multiforme ( allergic reaction or infection of the skin), accumulation of fluid in the larynx, anaphylactic shock (severe allergic reaction ), anemia (decreased red blood cell count ), hepatitis (hepatitis), severe renal impairment, blood in the urine, difficulty urinating, disease of the stomach or intestines, vertigo.
How to store Pinex Strawberry
Keep out of sight and reach of children and young people.
Do not use this medicine after the expiry date which is stated on the sachet and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in the original package. Sensitive to light. Moisture sensitive
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.
Contents of the package and other information
Content declaration
- The active substance is paracetamol . One sachet contains 250 mg paracetamol .
- The other ingredients are sorbitol (E420), talc, butylated methacrylate copolymer basic, magnesium oxide light, carmellose sodium, sucralose, magnesium stearate ( Ph . EUR.), Hypromellose, stearic acid, sodium lauryl sulfate, titanium dioxide (E171), simethicone, strawberry, malt gum (E414), natural and nature-identical flavors, propylene glycol (E1520), triacetin (E1518), maltol (E636)). Vanilla flavor (contains maltodextrin, natural and nature-identical flavors, propylene glycol (E1520), sucrose, sulfites).
What the medicine looks like and the contents of the pack
Granules, white or almost white, aluminum sachets.
Pinex Strawberry is available in the following pack sizes:
10, 20 sachets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer :
Losan Pharma GmbH
Otto-Hahn-Str. 13
79395 Neuenburg
Germany