Penomax 200 mg, 400 mg Pivmecillinam Hydrochloride Film-coated Tablets
What Penomax Is And What Penomax Used For
The active substance in Penomax, pivmecillinam, is an antibiotic that belongs to a group of medicines called penicillins. Penomax works by killing the bacteria that cause infection. If an infection is not treated, the bacteria can continue to grow in your body.
Penomax used for to treat urinary tract infections.
Pivmecillinam contained in Penomax 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 You Take Penomax
Do Not Take Penomax
- If you are allergic to pivmecillinam or any of the other ingredients of this medicine (listed in section 6)
- If you are allergic to penicillin or cephalosporins
- If you have a known narrowing of the esophagus and/or obstruction in the gastrointestinal tract
- If you have a known hereditary metabolic disorder such as the condition that can reduce the amount of a substance called carnitine in your body
- If you have a known hereditary metabolic disorder that causes you to have too much acid in your blood (acidemia) or urine (aciduria).
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before taking Penomax if:
- You have known porphyria (a rare metabolic disorder)
- You have known carnitine ( amino acid ) deficiency
- You have unstable diabetes or abnormally low muscle mass
- You experience severe diarrhea during treatment with Penomax
Other Medicines And Penomax
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The effect of certain medicines may be affected and some medicines may affect the effect of Penomax if used at the same time.
You must tell your doctor if you are taking any of the following medicines:
- Methotrexate (used to treat rheumatism, cancer, and psoriasis )
- Probenecid (used to treat gout )
- Valproic acid or valproate (medicines used to treat epilepsy )
- Any other antibiotic (for the treatment of infections, such as erythromycin or tetracycline ).
Penomax With Food And Drink
The tablets should be swallowed whole with at least half a glass of liquid while sitting or standing up (see section 3. How to take Penomax). You must take the medicine with plenty of fluids. This prevents you from getting inflammation in the esophagus. Read section 4 of this leaflet so that you know the signs if this happens to you.
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
Penomax can be used during pregnancy if your doctor thinks it is necessary.
Breast-feeding
Penomax can be used during breastfeeding.
Fertility
No clinical fertility studies have been performed.
Driving And Using Machines
Penomax has no or negligible influence on the ability to drive and use machines. Contact your doctor if you experience any side effects that may prevent you from driving or using 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.
How To Take Penomax
- Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Use for children and adolescents.
- The recommended dose for adults and adolescents is:
- 200‑400 mg 3 times daily.
- The recommended dose for children over 5 years is:
- Penomax 200 mg English 3 times daily.
- Take the tablets in a sitting or standing position. Drink at least half a glass of water or other beverage while taking the tablet. The tablets should preferably be taken with a meal to avoid stomach upset.
If You Take More Penomax Than You Should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
An overdose is likely to cause
- Nausea
- Vomiting
- Inflammation of the stomach
- Gastritis
If You Forget To Take Penomax
Take the missed dose as soon as you remember. Take the following dose only after 4 hours so that the amount of medicine is kept at a steady level in the body. Then continue to take the medicine as prescribed. Remember to take the medicine regularly.
Do not take a double dose to make up for a forgotten dose.
If You Stop Taking Penomax
Take the tablets for as long as your doctor prescribes them. You must take the entire course of treatment, even if you feel better after a few days. If you stop taking the medicine too soon, your symptoms may return.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible Penomax Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects are to look out for
Contact a doctor immediately if you get any of the following symptoms. You may have had an allergic reaction (a very rare Penomax side effects that may affect up to 1 in 10,000 people):
- You have difficulty breathing
- Your face or neck swells up
- Your skin develops severe rashes or areas of sudden swelling.
- You must get emergency medical help if you have the following symptoms:
- Severe diarrhea
This can be caused by inflammation of the colon.
Other possible side effects are
Common Penomax side effects: may affect up to 1 in 10 people
- Nausea
- Vomiting
- Diarrhea
Uncommon side effects: may affect up to 1 in 100 people
- Rash
Rare side effects: may affect up to 1 in 1,000 people
- Hives
- Decreased concentration of the amino acid carnitine in your body (which can cause fatigue or muscle weakness).
Very rare side effects: may affect up to 1 in 10,000 people
- Altered blood levels (decreased number of leukocytes or platelets, increased number of eosinophils )
- Inflammation of the esophagus
- Disorder of liver function
- Drug-induced fever
- Superinfection of Candida
How To Store Penomax
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date (EXP 🙂 which is stated on the blister, carton, and can. The expiration date is the last day of the specified month.
- Jar: Close the jar tightly. Moisture sensitive.
- Blister: Do not store above 30 ° C. Store in the original package. 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 Pack And Other Information
Marketing Authorization Holder And Manufacturer
Content declaration
- The active substance is pivmecillinam hydrochloride. Each film-coated tablet contains 200 mg or 400 mg.
- The other ingredients in the tablet core are microcrystalline cellulose and magnesium stearate.
- The other ingredients in the film coating are hypromellose and triacetin.
What the medicine looks like and the contents of the pack
- Penomax 200 mg English film-coated tablets:
- White to off-white round, biconvex film-coated tablets marked with “F” on one side and “48” on the other side.
- Penomax 400 mg film-coated tablets:
- White to off-white, oval, biconvex film-coated tablets with beveled edges, marked with “T” on one side and “64” on the other side.
- Pack sizes :
- 200 mg film-coated tablets:
- Blisters: 9, 14, 15, 20, 30 and 40 tablets
- Can: 9, 14, 15, 20, 30, 40 and 100 tablets. The jar contains desiccant (bag of silica gel).
- Penomax 400 mg film-coated tablets:
- Blister: 10, 15, and 20 tablets.
- Jar: 10, 15, and 20 tablets. The jar contains desiccant (bag of silica gel).
- Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB
medinfo@orionpharma.com
This medicinal product is authorized under the European Economic Area under the names:
- Denmark
- Finland
- Norway
- Sweden
- Iceland: Penomax