Selexid 200 mg and 400 mg film-coated Pivmecillinam Hydrochloride Tablets
What Selexid Is And What Selexid Is It Used For
This medicine belongs to a group of medicines called penicillins, it is a type of antibiotic.
Selexid works by killing the bacteria that cause infection in the bladder or ureters (urinary tract infection).
Pivmecillinam contained in Selexid may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have further questions, and always follow their instructions.
What You Need To Know Before Taking Selexid
Do Not Take
- If you are allergic to pivmecillinam, other penicillins, or any of the other ingredients of this medicine (listed in section 6).
- If you have a narrowing of the esophagus.
- If you have a hereditary metabolic disorder that may reduce the amount of a substance in your body called carnitine or which may increase the acid levels in your blood or urine.
Warnings And Cautions
Talk to your doctor before taking Selexid
- If you are allergic to other antibiotics, e.g. cephalosporin.
- If you have porphyria (a metabolic disorder).
- If you have been taking the medicine for a long time (as it increases the risk of carnitine deficiency).
If you are pregnant and taking it just before delivery, it may affect some tests that are taken to check if your newborn baby has hereditary metabolic disorders, see the section Pregnancy and breast-feeding.
Other Medicines And Selexid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of the treatment can be affected if this medicine is taken at the same time as certain other medicines, so tell your doctor if you are taking:
- Probenecid (anti-gout medicine ) may increase the effect of Selexid
- Methotrexate (for arthritis ) can have a greatly increased effect and become toxic.
- Other antibiotics (eg erythromycin or tetracycline ) may counteract the effect of Selexid
- Valproate or valproic acid (medicines for epilepsy ) may increase the risk of carnitine deficiency.
Selexid With Food And Drink
- Selexid can be taken with or without food.
Take the tablets with at least half a glass of water. It is important to take the medicine with plenty of fluid to avoid esophageal problems. For a description of such problems, see section 4 Possible side effects.
Pregnancy And Breastfeeding
Pregnancy
Selexid can be used during pregnancy if your doctor thinks it is necessary. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Cases of false-positive tests in newborns that show a metabolic disorder called isovaleric acidemia have been reported. Taking Selexid just before delivery can affect these tests and give a false-positive result. A false-positive result means that the test incorrectly shows that your child has the disorder. It does not pose a risk to the newborn, but you should tell your doctor if you have taken Selexid just before delivery.
Breast-feeding
Selenide can be used during breastfeeding.
Driving And Using Machines
Selexid 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.
Selexid How To Take
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Selexid 200 mg uses
- Your doctor will tell you how many tablets you or your child should take and how many times a day the medicine should be taken.
- Distribute the doses evenly over the day, e.g. when dosing 3 times daily take one tablet at breakfast, one tablet at lunch, and one tablet at dinner.
- Remember to always take the tablets with at least half a glass of water and not in a supine position.
- Adults :
- 200 mg twice daily for 7 days
- Alternatively 200 mg 3 times daily for 5 days.
- Or 400 mg 2-3 times daily for 3 days.
- In case of difficult-to-treat infections, Selexid can be dosed 200 mg 3 times daily for 10 days.
- Children over 5 years: 200 mg 3 times daily.
If You Take More Selexid Than You Should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If You Forget To Take Selexid
If you forget to take your medicine, take the missed dose as soon as you remember. Always take the tablets with at least half a glass of water. Then take the next dose at the usual time.
If You Stop Taking Selexid
It is important to take all medicines prescribed by your doctor. Complete the entire tablet treatment even if you feel better. Otherwise, there is a risk that the disease will return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Selexid Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects are to be observant of:
Stop taking Selexid and contact a doctor immediately if you experience any of the following symptoms of severe allergic reactions (anaphylactic reactions including anaphylactic shock ):
- Swelling of the face, lips, tongue, or throat
- Difficulty swallowing
- Hives
- Sudden skin rash
- Difficulty breathing
- Dizziness
These reactions can be life-threatening (occurring in an unknown number of users).
If you develop severe diarrhea during treatment with Selexid, contact your doctor immediately.
- Diarrhea may be due to an inflammation of the colon ( colitis, may occur in up to 1 in 100 patients).
Other Selexid side effects:
Common (may affect up to 1 in 10 people)
- Diarrhea
- Nausea
- Fungal infection of the vagina.
Uncommon Selexid side effects (may affect up to 1 in 100 people)
- Rash
- Hives ( urticaria )
- Itching
- Low platelet count (affects blood clotting ability, may be due to bruising or bleeding more easily
- Headache
- Dizziness
- Vomiting
- Abdominal pain
- Indigestion
- Sores in the esophagus
- Inflammation of the esophagus
- Sores in the mouth
- Abnormal liver function (can be seen using blood tests)
- Fatigue
Rare (may affect up to 1 in 1,000 people)
- Low carnitine value (may cause symptoms such as muscle weakness, fatigue, or decreased energy.
How To Store Selexid
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton 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 Packaging And Other Information
Content Declaration
- The active substance is pivmecillinam hydrochloride.
- Selexide contains 200 mg or 400 mg pivmecillinam hydrochloride per tablet.
- The other ingredients are hydroxypropylcellulose, hypromellose, microcrystalline cellulose, magnesium stearate, simethicone emulsion, and paraffin.
What The Medicine Looks Like And The Contents Of The Pack
- Selexid 200 mg is a white tablet marked with a lion on one side and 137 on the other.
- Pack sizes: 14, 15, 20, 30, 40 and 100 tablets.
- Selexid 400 mg is a white, capsule-shaped tablet.
- Pack sizes: 10, 15, and 20 tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Manufacturer:
Recipharm Strängnäs AB, Mariefredsvägen 35, 645 41 Strängnäs (200 mg and 400 mg).