150 mg film-coated tablets
roxithromycin
What Surlid is and what it is used for
Surlid contains the active substance roxithromycin. It is a macrolide antibiotic that interferes with the bacteria’s production of protein and thus prevents them from multiplying.
Surlid is used to treat:
- pneumonia and chlamydial infections in the vagina.
- inflammation of the ears, tonsils, and throat as well as skin and soft tissue infections in people who are hypersensitive (allergic) to penicillin or where penicillin is unsuitable for other reasons.
What you need to know before using Surlid
Do not use Surlid
- if you are allergic to roxithromycin, other macrolides, or any of the other ingredients of this medicine (listed in section 6).
- if you are simultaneously taking medications for migraines that contain, for example, ergotamine, dihydroergotamine, or so-called ergotamine alkaloids.
- if you are taking certain other medicines such as astemizole, cisapride, pimozide, or terfenadine (see section Other medicines and Surlid).
Warnings and precautions
Talk to your doctor or pharmacist before using Surlid if you have:
- impaired liver function.
- a heart disease.
- the muscle disease myasthenia gravis.
In case of severe diarrhea during treatment with Surlid, contact your doctor.
If a widespread, severe skin rash occurs, with symptoms such as blistering or scaling of the skin, as well as signs of flu and fever ( Stevens-Johnson syndrome ), general malaise, fever, chills and muscle aches ( toxic epidermal necrolysis ), or red, scaly rashes with lumps under the skin and blisters ( acute generalized exanthematous pustulosis ), you should see a doctor immediately because these skin reactions can be life-threatening.
Other medicines and Surlid
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. Surlid can affect or be affected by medicines containing the following active substances:
- ergot alkaloids (anti- migraine agents ). This combination must be avoided.
- digoxin and certain other drugs used in heart rhythm disorders (eg, quinidine, procainamide, disopyramide, dofetilide, amiodarone )
- midazolam (sleeping and sedative)
- cisapride (used for stomach and intestinal disorders)
- ciclosporin (agents that suppress the immune system)
- warfarin and other medicines are used to prevent blood clots.
- citalopram, tricyclic antidepressants (certain antidepressants)
- astemizole, terfenadine (anti-allergy )
- fluoroquinolones, rifabutin (certain antibiotics )
- fluconazole , pentamidine (certain antifungal agents)
- phenothiazines, pimozide (certain antipsychotics )
- telaprevir (certain antivirals)
- statins (lowers cholesterol levels in the blood)
- theophylline (dilates the airways)
- bromocriptine (dopamine inhibitor)
- methadone (morphine-like medicine used to treat severe chronic pain and for drug addiction withdrawal)
Surlid with food and drink:
Surlid tablets should be taken at least 15 minutes before a meal.
Pregnancy and breast-feeding:
The safety of using Surlid during pregnancy has not been established.
Passes into breast milk and should therefore not be used during breastfeeding.
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 using this medicine.
Driving ability and use of machinery
The use of Surlid can cause side effects such as dizziness, impaired vision, and blurred vision. This may affect your 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 increased 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. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Surlid contains glucose
If you have an intolerance to certain sugars, talk to your doctor before using this medicine because Surlid contains glucose.
How to use Surlid
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The dose is determined by the doctor who adjusts it individually for you.
The recommended dose for adults is 1 tablet 2 times daily (every 12 hours).
Surlid tablets should be taken at least 15 minutes before a meal.
Patients with impaired renal function: In case of impaired renal function, no change in dosage is needed.
Patients with impaired liver function: Use in mild-moderate impaired liver function should be done with caution. Treatment with Surlid is not recommended in severely impaired liver function.
Elderly: No change in dosage is needed for elderly people.
The entire Surlid regimen must be completed as prescribed. If treatment is stopped too early, bacteria can survive, multiply and cause a new infection.
If you have taken too much Surlid
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Surlid
Do not take a double dose to make up for a missed dose.
If you forget a dose, continue as usual until the entire course is completed.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Surlid and contact a doctor or hospital immediately if you experience any of the following symptoms:
Has been reported (occurring in an unknown number of users):
- swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing (may be signs of angioedema or anaphylactic shock (allergic shock)
- severe, persistent, and/or bloody diarrhea during or after treatment with Surlid (may be due to a type of intestinal inflammation called pseudomembranous colitis )
- infection with symptoms such as fever with the greatly worsened general condition or fever with local symptoms of infection such as sore throat/pharynx/mouth or difficulty urinating, (may be due to impaired immune system due to the reduced number of white blood cells, agranulocytosis )
- severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes) ( toxic epidermal necrolysis )
- an extremely strong allergic reaction with a skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as the genitals ( Stevens-Johnson syndrome )
- red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis )
Other side effects include:
Common (may affect up to 1 in 10 users):
- Stomach problems in the form of nausea, vomiting, diarrhea, pain, and stomach cramps
- Headache and dizziness
- Rash.
Uncommon (may affect up to 1 in 100 users):
- Effect on the blood picture (eosinophilia
- Skin rash (erythema multiforme), hives
Has been reported (occurring in an unknown number of users) :
- Superinfection during long-term treatment (an infection that occurs during or shortly after treatment of another infection )
- decreased number of white blood cells ( neutropenia ), decreased number of platelets ( thrombocytopenia )
- hallucinations, confusion
- crawling and tingling
- disturbances of the sense of taste and/or smell
- spasm in the musculature of the trachea
- impaired vision, vision problems (blurred vision)
- temporary deafness, slightly impaired hearing, dizziness, tinnitus
- change in heart rhythm
- bloody diarrhea
- inflammation of the pancreas
- acute liver damage, elevated liver values
- small bleedings in the skin and mucous membranes (purpura)
How Surlid should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after (Exp or EXP). The expiration date is the last day of the specified month.
Store at a maximum of 25 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance roxithromycin is 150 mg per tablet.
- Other ingredients are hydroxypropyl cellulose, poloxamer, povidone, anhydrous colloidal silicon dioxide, magnesium stearate, talc, corn starch, hypromellose, anhydrous glucose, titanium dioxide (E 171), propylene glycol.
Appearance and package sizes of the medicine
20 tablets in printed packaging
Marketing Authorisation Holder
Sanofi AB
Box 30052
104 25 Stockholm
Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France