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Pilocarpine

Pilocarpin Agepha, Pilocarpin Puroptal, Salagen · ATC code S01EB01

Also known as: Pilocarpin, Pilokarpin · Brand names: Pilocarpin Agepha, Pilocarpin Puroptal, Salagen, Pilocarpinhydrochlorid Bay Pharma, Pilocarpinhydrochlorid Smartpractice Europe, Spersacapin, Spersacarpin, Pilokarsol %, Pilosed %, Qlosi

Key facts
Active substance
Pilocarpine
ATC code
S01EB01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Pilocarpine is, per the US prescribing information, a cholinergic parasympathomimetic tablet that increases saliva and is used for dry mouth after head and neck radiotherapy and in Sjogren's syndrome.

What it is used for

  • Dry mouth from salivary gland hypofunction caused by radiotherapy for head and neck cancer.
  • Dry mouth in patients with Sjogren's syndrome.

Dosing

  • Head and neck cancer: start with 5 mg three times a day, titrated to response and tolerance; usual range up to 15-30 mg per day, not exceeding 10 mg per dose; at least 12 weeks of uninterrupted therapy may be needed to assess response.
  • Sjogren's syndrome: 5 mg four times a day; efficacy was established by 6 weeks of use.
  • Moderate hepatic impairment: start with 5 mg twice daily; no reduction in mild impairment; not recommended in severe impairment.
  • Use the lowest tolerated and effective dose for maintenance.

Contraindications

  • Uncontrolled asthma.
  • Known hypersensitivity to pilocarpine.
  • When miosis is undesirable, e.g. acute iritis or narrow-angle glaucoma.

Important warnings

  • Patients with significant cardiovascular disease may not compensate for transient changes in hemodynamics or rhythm.
  • Visual disturbances, especially at night, may impair the ability to drive safely.
  • Increased airway resistance: caution in controlled asthma, chronic bronchitis or COPD.
  • Caution in cholelithiasis or biliary tract disease and in nephrolithiasis (possible renal colic).
  • Excessive sweating with inadequate fluid intake can lead to dehydration.

Side effects

  • In head and neck cancer (10 mg three times a day): sweating 68%, nausea 15%, chills 15%, rhinitis 14%, flushing 13%, urinary frequency 12%, dizziness 12%, asthenia 12%.
  • Others: headache, dyspepsia, lacrimation, edema, vomiting, hypertension.
  • The most common adverse events increase with dose.

Interactions

  • Beta-adrenergic antagonists: caution because of possible conduction disturbances.
  • Other parasympathomimetic drugs have additive effects; pilocarpine may antagonize anticholinergic drugs (e.g. atropine, inhaled ipratropium).

Pregnancy and breastfeeding

  • There are no adequate studies in pregnant women; use only if the potential benefit justifies the risk to the fetus.
  • It is not known whether pilocarpine is excreted in human milk.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • Pilocarpin AgephaAgepha Pharma S.R.O · 1 register entry
  • Pilocarpin PuroptalAgepha Pharma S.R.O · 1 register entry
  • SalagenMerus Labs Luxco Ii S.À R.L. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Pilocarpinhydrochlorid Bay PharmaBay Pharma Gmbh · 1 register entry
  • Pilocarpinhydrochlorid Smartpractice EuropeSmartpractice Europe Gmbh · 1 register entry
  • SalagenMerus Labs Luxco Ii S.À R.L. · 1 register entry
  • SpersacapinOmnivision Gmbh · 1 register entry
  • SpersacarpinOmnivision Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • Pilokarsol %SANOVEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • Pilosed %BİLİM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • QlosiOrasis Pharmaceuticals, Inc. · 1 register entry
  • SalagenAdvanz Pharma (US) Corp. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 17 more European countries
Belgium
Isopto
Bulgaria
Пилокарпин Вижън
Cyprus
Prothenol
Finland
Isopto Carpine, Salagen
France
Isopto, Pilocarpine Faure, Salagen
Greece
Cidren, Dryboka, Isopto-Carpine, Pilocollyre, Prothenol, Salagen, Sumario, Xerocarp, Xerosal
Hungary
Salagen
Ireland
Minims
Italy
Dropilton, Pilocarpina Farmigea, Salagen
Luxembourg
Isopto, Spersacapin, Spersacarpin
Netherlands
Minims Pilocarpinenitraat Bausch + Lomb Ireland Limited, Salagen
Norway
Minims
Poland
Pilocarpinum Wzf
Portugal
Salagen
Slovenia
Salagen
Spain
Colircusí, Pilocarpina Apotheke, Salagen
Sweden
Pilokarpin Karo Pharma, Salagen

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Pilocarpine hydrochloride (Actavis Pharma, Inc.) – Prescribing Information, 2021-08-31. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=610022b7-7dc9-405a-a580-104657f43bdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.