50 mg/ml powder for oral suspension
phenoxymethylpenicillin potassium
What Primve 50 mg / ml oral suspension powder is and what it is used for
Primve contains the active substance phenoxymethylpenicillin (which belongs to the antibiotic group penicillins ). This type of drug prevents the bacterium from building a normal cell wall. Without a functioning cell wall, the bacterium dies quickly.
Primve is used to treat sore throat, sinusitis, ear infections, pneumonia, bacterial infections of the skin and soft tissues, Lyme disease, and dental infection in adults and children.
Phenoxymethylpenicillin potassium contained in Primve 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 using Primve 50 mg/ml powder for oral suspension
Do not use Primve 50 mg/ml powder for oral suspension
- if you (or your child) are allergic (hypersensitive) to phenoxymethylpenicillin, other penicillins, or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before you (or your child) take Primve
- if you are hypersensitive to cephalosporins (another group of antibacterial drugs)
- if you have or have had allergic diseases or bronchial asthma
If you get a rash, fever, and/or facial swelling, stop treatment and consult a doctor.
Other medicines and Primve 50 mg/ml powder for oral suspension
Tell your doctor or pharmacist if you (or your child) are taking, have recently taken, or might take any other medicines.
Primve may affect or be affected by other medicines:
- certain medicines for tumors and disorders of the immune system (methotrexate)
- medicines for gout (probenecid).
Primve 50 mg/ml powder for oral suspension with food, drink, and alcohol
Primve has the best effect if taken on an empty stomach, ie. at least 1 hour before or 2 hours after a meal.
It is easier to get children to take Primve with a meal.
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.
Pregnancy
Primve can be used during pregnancy.
Breast-feeding
Primve passes into breast milk, but you can use Primve even if you are breastfeeding.
Fertility
There are no known risks associated with the use of the drug in terms of fertility.
Driving and using machines
This medicine has no or negligible effect on the ability to drive and use machines.
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.
Primve contains aspartame, fructose, and potassium
- Aspartame: Contains a source of phenylalanine. May be harmful to people with phenylketonuria.
- Fructose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. May be harmful to teeth when taken for a long time. Careful dental hygiene is important during treatment.
- Potassium: This medicine contains 128.7 mmol (or 5.0 mg / ml). This should be considered by patients with impaired renal function or patients on a low-potassium diet.
How to use Primve 50 mg/ml powder for oral suspension
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The daily dose depends on your age, weight, infection, and severity. You should follow your doctor’s instructions on the dosage and duration of treatment.
Before Primve is prepared at the pharmacy, it is a powder. You should shake the bottle well before use to make sure that the suspension is well mixed.
If you use more Primve than you should 50 mg/ml powder for oral suspension
If you have taken too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Symptoms of overdose include nausea, vomiting, diarrhea, altered level of consciousness, salt balance disorders, muscle twitching, seizures, unconsciousness ( coma ), severe anemia and jaundice, and renal failure.
If you forget to use Primve 50 mg/ml powder for oral suspension
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you stop using Primve 50 mg/ml powder for oral suspension
Even if you feel better after a few days, it is important to take the entire treatment regimen with Primve according to prescription one. Otherwise, some bacteria may survive, start growing and cause a new infection.
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 Primve and contact a doctor immediately if you get any of the following symptoms of life-threatening side effects.
- shortness of breath, rash or itching, swelling of the skin especially on the lips, face, or tongue (within minutes to hours) due to hypersensitivity (anaphylactic reaction/shock). (Rare side effects may affect up to 1 in 1,000 people.)
- Severe rash with flaking and blistering (erythema multiforme). (Uncommon side effects may affect up to 1 in 100 people.)
- Decreased number of white blood cells, which causes fever and severe deterioration of the general condition or fever with symptoms of local infection such as sore throat or mouth or urinary problems ( agranulocytosis ). (Very rare side effects may affect up to 1 in 10,000 people.)
Other side effects ar
Common (may affect up to 1 in 10 people)
- Nausea, diarrhea.
- Rash.
Uncommon side effects (may affect up to 1 in 100 people)
- High levels of eosinophil are in the blood (a type of blood cell ).
- Vomiting, stomatitis ( infection of the mouth), inflammation of the tongue, indigestion.
- Urticaria, skin rash with scaling, swelling of the skin or mucous membranes.
- Joint pain.
- Fever.
Very rare (may affect up to 1 in 10,000 people)
- Symptoms of anemia such as pale skin, fatigue, fever (hemolytic anemia ), tendency to get an infection ( leukopenia ), tendency to get bruises, small round spots on the skin due to bleeding ( petechiae ), and bleeding in mucous membranes ( thrombocytopenia ).
- Itching.
- A positive result on the Coombs test (test for hemolytic anemia ).
No known frequency (can not be calculated from the available data)
- Intestinal infections (pseudomembranous colitis ).
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of your medicine.
The Medical Products Agency
Box 26
751 03 Uppsala
How to store Primve 50 mg/ml powder for oral suspension
Keep this medicine out of the sight and reach of children.
Powder for oral suspension: Do not store above 30 ° C
Suspension should be stored in a refrigerator (2 ° C ‑ 8 ° C). It should be used within 14 days after preparation at the pharmacy/hospital.
Do not use this medicine after the expiry date which is stated on the carton or bottle 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.
Contents of the pack and other information
Content declaration
- The active substance is phenoxymethylpenicillin potassium. After reconstitution at the pharmacy, 1 ml contains 50 mg of phenoxymethylpenicillin potassium.
- The other ingredients are Aspartame (E951), fructose, povidone (E1201), anhydrous colloidal silica, titanium dioxide (E171), sodium citrate (E331), citric acid (E330), orange flavor (maize maltodextrin, flavoring agent, alpha-Tocopherol, caramel flavor (corn maltodextrin, flavoring, propylene glycol (E1520)).
What the medicine looks like and the contents of the pack
Powder for oral suspension: White to almost white powder, fruit flavor.
Prepared suspension: Homogeneous white or off-white suspension with fruit flavor.
Amber glass bottle with screw cap made of HDPE.
Pack sizes:
125 ml and 200 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
2care4 Generics ApS
Stenhuggervej 12-14
6710 Esbjerg V
Denmark
Manufacturer
Atral Laboratories, SA
Rua da Estação 42, Vala do Carregado 2600 – 726
Castanheira do Ribatejo
Portugal
Informed
C / Torre de los Herberos, 35
PI “Carretera de la Isla”,
Dos Hermanas, 41703 Sevilla
Spain