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Dr. Falk Pharma UK Ltd

Unit K, Bourne End, Business Park, Cores End Road, Bourne End, SL8 5AS
Telephone: +44 (0)1628 536 600
Fax: +44 (0)1628 536 601
Medical Information Direct Line: +44 (0)1628 536 616
Customer Care direct line: +44 (0)1628 536 600
Medical Information Facsimile: +44 (0)1628 536 601
Stock Availability: +44 (0)1628 536 600


Summary of Product Characteristics last updated on medicines.ie: 07/03/2012
SPC Salofalk 250mg gastro-resistant tablets



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1. NAME OF THE MEDICINAL PRODUCT

Salofalk 250mg Gastro-Resistant Tablets


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 250 mg of mesalazine.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Gastro-resistant tablet

Round, biconvex, yellow tablets.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

As an anti-inflammatory in the management of ulcerative colitis, and in the treatment of Crohn's disease.


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4.2 Posology and method of administration

Salofalk Tablets are for oral administration.

Adults including the elderly:

When symptoms of acute inflammation are present, 2 Salofalk 250 tablets should be taken with ample fluid in the morning, afternoon and evening after meals, unless otherwise prescribed. In severe cases of the diseases the dosage may be doubled. (Generally an acute attack endures 8 – 12 weeks. A high dose therapy with Salofalk 250 should not last longer).

As maintenance therapy to prevent recurrence, 2 tablets should be taken in the morning, afternoon and evening.

Children: There is only limited documentation for an effect in children (age 6 -18 years).

Children 6 years of age and older:

Active disease: To be determined individually, starting with 30-50mg/kg/day in divided doses. Maximum dose: 75mg/kg/day. The total dose should not exceed the maximum dose for adults.

Maintenance treatment: To be determined individually, starting with 15-30mg/kg/day in divided doses. The total dose should not exceed the recommended dose for adults.

It is generally recommended that half the adult dose may be given to children up to a body weight of 40kg and the normal adult dose to those above 40kg.


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4.3 Contraindications

Salofalk is contraindicated in cases of:

Known hypersensitivity to salicylates or any of the excipients

Sever impairment of hepatic or renal function.


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4.4 Special warnings and precautions for use

Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, follow up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks.

If the findings are normal, follow up tests should be carried out every 3 months. If additional symptoms occur, these tests should be performed immediately.

Caution is recommended in patients with impaired hepatic function.

Salofalk 250mg tablets should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment.

Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Salofalk tablets.

Patients with a history of adverse drug reactions to preparations containing sulfasalazine should be kept under close medical surveillance on commencement of a course of treatment with Salofalk 250mg tablets. Should Salofalk 250mg tablets cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.

This product contains 48mg of sodium per tablet. To be taken into consideration by patients on a sodium controlled diet.


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4.5 Interaction with other medicinal products and other forms of interaction

Specific interaction studies have not been performed.

In patients who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine should be taken into account.

There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.


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4.6 Pregnancy and lactation

There are no adequate data from the use of Salofalk tablets in pregnant women. However, data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on pregnancy or on the health of the foetus/newborn child. To date no other relevant epidemiologic data are available. In one single case after long-term use of a high dose mesalazine (2-4g, orally) during pregnancy, renal failure in a neonate was reported.

Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.

Salofalk tablets should only be used during pregnancy if the potential benefit outweighs the possible risk.

N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are excreted in breast milk. Only limited experience during lactation in women is available to date. Hypersensitivity reactions such as diarrhoea in the infant cannot be excluded. Therefore, Salofalk tablets should only be used during breast-feeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, breast-feeding should be discontinued.


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4.7 Effects on ability to drive and use machines

No effects on the ability to drive and use machines have been observed.


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4.8 Undesirable effects

Organ Class System

Frequency according to MedDRA convention

 

Rare

(≥ 1/10,000; < 1/1,000)

Very rare

(< 1/10,000)

Blood and lymphatic system disorders

 

Altered blood counts (aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia)

Nervous system disorders

Headache, dizziness

Peripheral neuropathy

Cardiac disorders

Myocarditis, pericarditis

 

Respiratory, thoracic and mediastinal disorders

 

Allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis)

Gastrointestinal disorders

Abdominal pain, diarrhoea, flatulence, nausea, vomiting

Acute pancreatitis

Renal and urinary disorders

 

Impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency

Skin and subcutaneous tissue disorders

 

Alopecia

Musculoskeletal and connective tissue disorders

 

Myalgia, arthralgia

Immune system disorders

 

Hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis

Hepatobiliary disorders

 

Changes in liver function parameters (increase in transaminases and parameters of cholestasis), hepatitis, cholestatic hepatitis

Reproductive system disorders

 

Oligospermia (reversible)


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4.9 Overdose

There are rare data on overdosage (e.g., intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Intestinal anti-inflammatory agent

ATC code: A07EC02

The mechanism of the anti-inflammatory action is unknown. The results of in vitro studies indicate that inhibition of lipoxygenase may play a role.

Effects on prostaglandin concentrations in the intestinal mucosa have also been demonstrated. Mesalazine (5-aminosalicylic acid/5-ASA) may also function as a radical scavenger of reactive oxygen compounds.

Mesalazine, orally administered, acts predominantly locally at the gut mucosa and in the submucous tissue from the luminal side of the intestine. It is important, therefore, that mesalazine is available at the regions of inflammation. Systemic bioavailability/plasma concentrations of mesalazine therefore are of no relevance for therapeutic efficacy, but rather a factor for safety. In order to fulfil these criteria Salofalk tablets are coated with Eudragit L; they are thus gastro-resistant and release of mesalazine is pH dependent.


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5.2 Pharmacokinetic properties

General considerations of mesalazine:

Absorption:

Mesalazine absorption is highest in proximal gut regions and lowest in distal gut areas.

Biotransformation:

Mesalazine is metabolised both pre-systemically by the intestinal mucosa and the liver to the pharmacologically inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). The acetylation seems to be independent of the acetylator phenotype of the patient. Some acetylation also occurs through the action of colonic bacteria. Protein binding of mesalazine and N-Ac-5-ASA is 43 % and 78 %, respectively.

Elimination:

Mesalazine and its metabolite N-Ac-5-ASA are eliminated via the faeces (major part), renally (varies between 20 and 50 %, dependent on kind of application, pharmaceutical preparation and route of mesalazine release, respectively), and biliary (minor part). Renal excretion predominantly occurs as N-Ac-5-ASA. About 1 % of total orally administered mesalazine dose is excreted into the breast milk mainly as N-Ac-5-ASA.


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5.3 Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenicity (rat) or toxicity to reproduction.

Kidney toxicity (renal papillary necrosis and epithelial damage in the proximal convoluted tubule or the whole nephron) has been seen in repeat-dose toxicity studies with high oral doses of mesalazine. The clinical relevance of this finding is unknown.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Anhydrous sodium carbonate (E500)

Glycine

Povidone

Microcrystalline cellulose

Colloidal anhydrous silica

Calcium stearate

Coating agents:

Hypromellose

Eudragit L/P [Poly (methacrylic acid, methyl methacrylate]

Talc

Titanium dioxide (E171)

Yellow ferric oxide (E172)

Basic Butylated Methacrylate Copolymer [Eudragit E]

Macrogol 6000


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years.


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

PVC/PVDC/aluminium blister packs packed in cardboard cartons containing 100 or 300 tablets.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Dr. Falk Pharma GmbH

Leinenweberstr. 5

79108 Freiburg

Germany


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8. MARKETING AUTHORISATION NUMBER(S)

PA 573/4/3


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 11 October 1989

Date of last renewal: 11 October 2009


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10. DATE OF REVISION OF THE TEXT

02/2012



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Active Ingredients

 
   Mesalazine